Information Technology Jobs in Research Triangle Park

Why USAA?

At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the #1 choice for the military community and their families.

Embrace a fulfilling career at USAA, where our core values - honesty, integrity, loyalty and service - define how we treat each other and our members. Be part of what truly makes us special and impactful.

The Opportunity

As a dedicated Property Adjuster Specialist , you will work within established guidelines and framework to investigate, evaluate, negotiate, and settle complex property insurance claims presented by or against our members. You will confirm and analyzes coverage, recognize liability exposure and negotiate equitable settlements in compliance with all state regulatory requirements.

Property Adjuster Specialist focus on using technology and desk adjusting for a virtual first approach to inspections and claims handling. USAA also provides a company vehicle to physically inspect losses within your locally assigned territory. Field Adjusters may travel outside of their local territory to respond to claims in other regions when needed. This is an hourly, non-exempt position with paid overtime available.

This is a field-based role for the area of Durham, NC. Candidates currently living in this location or willing to self-relocate are encouraged to apply.

• Proactively manages assigned claims caseload comprised of complex damages that require commensurate knowledge and understanding of claims coverage including potential legal liability.

• Partners with vendors and internal business partners to facilitate complex claims resolution. May also involve external regulatory coordination to ensure appropriate documentation and compliance.

• Investigates claim damages by conducting research from various sources, including the insured, third parties, and external resources. May identify and resolve potential discrepancies and identifies subrogation potential resulting from unusual characteristics.

• Identifies coverage concerns, reviews prior loss history, determines and creates Special Investigation Unit (SIU) referrals, when appropriate. Determines coverage through analyzing information involving complex policy terms and contingencies.

• Determines and negotiates complex claims settlement within authority limits. Develops recommendations and collaborates with management for determining settlement amounts outside of authority limits and accurately manages claims outcomes.

• Maintains accurate, thorough, and current claim file documentation throughout the claims process.

• Advance knowledge of estimating technology platforms and virtual inspection tools. Utilizes platforms and tools to prepare claims estimates to manage complex property insurance claims.

• Supports workload surges and catastrophe (CAT) response operations as needed, including mandatory on-call dates and potential evening, weekend, and/or holiday work outside normal work hours.

• May be assigned CAT deployment travel with minimal notice during designated CATs.

• Works various types of claims, including ones of higher complexity, and may be assigned additional work outside normal duties as needed.

• Works independently solving complex problems with minimal guidance; acts as a resource for colleagues with less experience.

• Adjusts complex claims with attorney involvement.

• Recognizes and addresses jurisdictional challenges such as applicable legislation and construction considerations.

• May require travel to resolve claims, attend training, and conduct in-person inspections.

• Ensures risks associated with business activities are effectively identified, measured, monitored, and controlled in accordance with risk and compliance policies and procedures.

• High School Diploma or General Equivalency Diploma required.

• 2 years of relevant property claims adjusting experience of moderate complexity losses that includes writing estimates, involving dwelling and structural damages.

• Advanced knowledge of estimating losses using Xactimate or similar tools and platforms.

• Proficient knowledge of residential construction.

• Proficient knowledge of property claims contracts and interpretation of case law and state laws and regulations.

• Proficient negotiation, investigation, communication, and conflict resolution skills.

• Proven investigatory, analytical, prioritizing, multi-tasking, and problem-solving skills.

• Ability to travel 50-75% of the year (local & non-local) and/or work catastrophe duty when needed.

• Acquisition and maintenance of insurance adjuster license within 90 days and 3 attempts.

• US military experience through military service or a military spouse/domestic partner

• 5 years of prior carrier field experience handling higher severity/complex losses (i.e. vandalism, malicious mischief, foreclosures, earth movement, collapse, liability, etc.)

• Prior experience adjusting property claims using virtual technologies

• Prior property field adjuster experience handling DWG, APS and ALE adjustments

• Industry designations such as AINS, CPCU, AIC, SCLA (or actively pursuing)

• Xactimate Level 1 and/or Level 2 certification

• Prior deployments in support of catastrophes

• Currently hold an active Adjuster License

• Currently reside within or have the ability to self-relocate to Durham, NC

• May require the ability to crouch and stoop to inspect confined spaces, to include attics and go beneath homes into crawl spaces.

• May need to meet all USAA safe driving requirements including verification of driving record through MVR & possession of valid driver's license.

• May require the ability to lift a minimum of 35 pounds to include lifting a ladder in and out of the trunk of a car.

• May require the ability to climb ladders and traverse roofs, this includes the ability to work at heights while inspecting roofs and attics.

Compensation range: The salary range for this position is: $69,920.00 - $133,620.00.

USAA does not provide visa sponsorship for this role. Please do not apply for this role if at any time (now or in the future) you will need immigration support (i.e., H-1B, TN, STEM OPT Training Plans, etc.).

Compensation: USAA has an effective process for assessing market data and establishing ranges to ensure we remain competitive. You are paid within the salary range based on your experience and market data of the position. The actual salary for this role may vary by location.

Employees may be eligible for pay incentives based on overall corporate and individual performance and at the discretion of the USAA Board of Directors.

The above description reflects the details considered necessary to describe the principal functions of the job and should not be construed as a detailed description of all the work requirements that may be performed in the job.

Benefits: At USAA our employees enjoy best-in-class benefits to support their physical, financial, and emotional wellness. These benefits include comprehensive medical, dental and vision plans, 401(k), pension, life insurance, parental benefits, adoption assistance, paid time off program with paid holidays plus 16 paid volunteer hours, and various wellness programs. Additionally, our career path planning and continuing education assists employees with their professional goals.

For more details on our outstanding benefits, visit our benefits page on

Applications for this position are accepted on an ongoing basis, this posting will remain open until the position is filled. Thus, interested candidates are encouraged to apply the same day they view this posting.

USAA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

*This position qualifies for our UNC Health Johnston Incentive, ask your recruiter for more information.

Become part of an inclusive organization with over 40,000 teammates, whose mission is to improve the health and well-being of the unique communities we serve.

The Rex Surgery Center of Cary is a multispecialty free standing Ambulatory Surgery Center.

Hours 6:45-5:15pm Monday-Friday, no holidays, no weekends or call.

Summary: Possesses expertise in the theory and application of sterile aseptic technique and combines the knowledge of human anatomy, surgical procedures, and implementation tools and technologies to facilitate a surgeon's performance of invasive, therapeutic, and diagnostic procedures.

This position has a dual function in the operating room and the ambulatory setting and demonstrates competency in the care of surgical patients in the ambulatory surgical setting.

Responsibilities: Establishes and maintains sterile field and assures team maintains sterile environment.

Demonstrates and practices a good understanding of sterile technique.

Has advanced knowledge of instrumentations.

Prepares Operating Room with appropriate instrumentation, equipment and supplies.

Demonstrates correct and safe instrumentation passing and performs sponge, needle and instrument counts in a safe and accurate manner according to established policy.

Maintains technical skills to serve a patient population composed of infancy to geriatric clients.

Adheres to standards including but not limited to ASC policies and procedures, regulatory standards, and patient safety goals.

Assumes responsibility for self and ensures that the policies, procedures and safety practices of the Operating Room and ASC are reinforced.

Achieves target of room readiness on a consistent basis.

Serves as a role model to new employees and other staff members.

Serve as a resource and preceptor to less experienced Surgical Techs.

Establishes and maintains sterile field and assure team maintains sterile environment independently.

Anticipate the needs of the surgical team.

Applies advanced knowledge of instrumentation for multispecialty cases.

Demonstrates appropriate and correct case preparation.

Competent at unit level.

Corrects deficiencies at the case level.

Communicate effectively with patients, staff members and physicians Hospital are reinforced.

Assists in Sterile Processing as needed to sterilize and package surgical instrument trays.

Other Information Other information: Education Requirements: ● High School Diploma or GED or ● Graduate of an accredited Surgical Technology or Nursing program or ● Graduate of a Military Training Program in Surgical Technology ● Formal education/training may be substituted for individuals with 5 years of experience as a surgical tech Licensure/Certification Requirements: ● Basic Life Support Professional Experience Requirements: ● Minimum of 3 years OR experience required ● Certified Surgical Technologist (CST) through The National Board of Surgical Technology and Surgical Assisting or Tech in Surgery (TS-C) through The National Center of Competency Testing preferred Knowledge/Skills/and Abilities Requirements: ● Successful completion of service specific portion of the UNC Health Surgical Technologist competencies.

● Strong communication skills/customer service relations ● Excellent organizational/priority setting skill ● Ability to function effectively as a mentor & team player ● Ability to demonstrate knowledge of anatomy relating to the surgical procedure and the instrumentation required in order to effectively anticipate the needs of the surgeon.

● Ability to set priorities and respond appropriately to actual and/or potential life-threatening situations.

● On-call (May be a requirement depending on the position).

Job Details Legal Employer: NCHEALTH Entity: UNC REX Healthcare Organization Unit: Rex Cary OR Services Work Type: Full Time Standard Hours Per Week: 40.00 Salary Range: $24.73
- $35.56 per hour (Hiring Range) Pay offers are determined by experience and internal equity Work Assignment Type: Onsite Work Schedule: Day Job Location of Job: US:NC:Cary Exempt From Overtime: Exempt: No This position is employed by NC Health (Rex Healthcare, Inc., d/b/a NC Health), a private, fully-owned subsidiary of UNC Heath Care System.

This is not a State employed position.

Qualified applicants will be considered without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

UNC Health makes reasonable accommodations for applicants' and employees' religious practices and beliefs, as well as applicants and employees with disabilities.

All interested applicants are invited to apply for career opportunities.

Please email if you need a reasonable accommodation to search and/or to apply for a career opportunity.

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At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.

About Duke University Hospital

Pursue your passion for caring with Duke University Hospital in Durham, North Carolina, which is consistently ranked among the best in the United States. The largest of Duke Health's four hospitals with 1062 patient beds, it features comprehensive diagnostic and therapeutic facilities, including a regional emergency/trauma center, an endo-surgery center, and more.

***This position is eligible for up to $8,000 Relocation***

***A Commitment Bonus of up to $25,000 is available for eligible radiation therapists with three or more years of experience***

A Commitment Bonus of up to $15,000 is available for eligible radiation therapists with less than three years of experience

Location: Duke University Hospital

General Description of the Job Class

Apply ionizing radiation to the patient (inclusive of pediatric, adult, and geriatric populations) in accordance with the prescription and instructions of the Radiation Oncologist and under the general supervision of the Chief Therapist.

Duties and Responsibilities of this Level

• Deliver accurately the prescribed planned course of radiation therapy with minimal supervision.
• Check prescription, diagnosis, chart and patient identification.
• Explain procedure to patient, means of communication during treatment and procedure to follow if emergency arises during treatment. *Reinforce Radiation Oncologist's advice to patient regarding reactions to treatment and their care.
• Prepare room and equipment for patient according to prescription regarding immobilization devices, field size, treatment distance, lead protection devices, etc.
• Transfer patient safely to treatment couch, giving special care to catheters, intravenous drips, etc.
• Check daily treatment time and delivers prescribed dose. *Maintain visual and audible communication with the patient during treatment.
• Maintain patient markings. Observe patient for unusual reactions and events and report accurate information to the nursing staff and/or Radiation Oncologist.
• Observe radiation safety measures for patient and personnel.
• Perform simulations.
• Assist in tumor localization procedures, preparation of immobilization devices, etc.
• Assist in dosimetry procedures (i.e. Prescription calculations).
• Obtain weekly port films and present such at chart rounds for review by Radiation Oncology staff.
• Assume weekly on- call status on a rotation basis. (Applies to Duke staff therapist only)
• Perform and document daily accelerator warm-up and QA procedures.(DRH and RCH)
• Maintain records of daily treatment and other records as required by department quality assurance and quality improvement activities.
• Perform mold room duties.(DRH and RCH)
• Secure and maintain supplies.
• Secure x-ray and lab reports as needed.
• Report erratic operation of equipment to Chief Radiation therapist, Radiation Physicist and/or Medical Engineer.
• Participate in departmental PI (Performance Improvement) activities.
• Assist in the hiring and orienting of new personnel.
• Attend weekly QA rounds, monthly therapy meetings, and educational in-services.
• Incorporate department and hospital policies and procedures into care provided.

Required Qualifications at this Level

Education

• Satisfactory completion of a 24 month course in radiology technology and a 12 month course in radiation therapy technology; or
• Satisfactory completion of a 24 month course in radiation therapy technology; or
• Registered nurse who has satisfactorily completed a 12-month course in radiation therapy technology; or
• Satisfactory completion of a Bachelor of Science degree in radiation therapy.

Experience

• One year clinical training in Radiation Therapy.

Degrees, Licensure, and/or Certification

• Current licensure as required by state or national authority and/or certification or board eligible in Radiation Therapy by the American Registry of Radiology Technology.
• Maintain ARRT certification in radiation therapy with a minimum of documented 12 hours of continuing education.

Knowledge, Skills, and Abilities

• Knowledge in principles, practices and procedures involved in the operation of ionizing radiographic and radiation therapy equipment.
• Knowledge of the human anatomy and proper positioning of the patient to provide treatment as prescribed.
• Ability to administer CPR in a medical emergency.

Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status.

Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideasan exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Required

Preferred

Job Industries

• Healthcare

Job Title: Director Process Development and Manufacturing, CMC

Department: CMC

Reports to: Chief Technical Officer

About the Company:  

Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutical company leading the development of transformative gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies to treat patients with other retinal and refractive disorders.

Job Summary: 

The Director of Process Development and Manufacturing will be the technical lead for development and manufacturing of assigned assets within the Opus gene therapy programs focusing on technical transfer and process development and execution supporting product development and manufacturing to achieve company goals and strategies. This includes working collaboratively with external partners (i.e. CDMOs, contract labs, suppliers) to develop technical studies, analyze complex data, make data driven decisions, and author, review, and approve technical and regulatory documents. The ideal candidate will have a deep technical understanding of AAV gene therapy upstream and downstream development and process optimization.  This role will directly interact with the CDMO/contract partners and be responsible for building and maintaining excellent working relationships. Knowledge of manufacturing platforms, consistent with AAV technology, at scales ranging from process development through GMP and PPQ activities. The candidate will be hands-on and expected to provide content to all these areas. 

Duties/Responsibilities: 

·      Work with Opus CDMO/contract manufacturing and laboratory partners to develop a phase appropriate robust manufacturing program to support the process development and engineering of pre commercial and commercial cGMP material to support pre-clinical studies, clinical trials, and commercial supply. 

·      Support, author, and review/approve manufacturing plans and documentation including technical transfer, batch records and documentation, product specifications, stability programs, bridging and comparability studies, and other reports utilizing phase appropriate QbD best practices.

·      Support, author, and review/approve manufacturing documentation including testing records, certificates of testing/analysis, campaign summary reports, investigations, etc. 

·      Support, author, and review/approve regulatory documentation including pINDs, INDs, agency responses, CMC meeting requests and briefing packages, and BLAs.   

·      Ensure proper reference standard material is in place, tested, and released for each product. Lead technology transfer between sites. 

·      Ensure regulatory requirements are in place to support manufacturing campaigns with respect to Master Cell Banks, Plasmids, Drug Substances, Drug Products, and Diluents, to prevent developmental delays and or interruptions to clinical programs or regulatory filings.

·      Perform the role of person in plant as needed at the Opus CDMO/contract manufacturing partner’s sites. Act as the CMC expert during audits and interactions with regulatory agencies. 

·      Manage work to project plans for multiple gene therapy programs in the preclinical, pre-IND, IND/clinical, and commercial stages. 

·      Identify and lead the resolution of operational and functional level challenges, work with program and/or function managers to escalate issues to senior management.

·       Hands on resolution to issues/content generation. Design effective and high-quality presentations and progress reports, as requested.

Supervisory Responsibilities: 

·      None 

Education and Experience: 

·      Master’s degree (minimum) from an accredited institution in a science or health-related field with minimum of 7-10 years of experience in the pharmaceutical or biotechnology industry. Ophthalmology experience is preferred.

·      Additionally, a minimum of 5 years of direct manufacturing experience for biopharmaceuticals. Preference will be given for direct AAV gene therapy experience. Previous CDMO/contract lab experience also preferred.

·      Experience designing and executing technical transfer and scale up campaigns and associated documentation.

·      Experience in writing and reviewing regulatory submissions including pINDs, INDs, Meeting Requests/Briefing Packages, Annual Report/DSUR’s, and BLAs. 

·      Experience with FDA and/or other regulatory agency requirements and interactions.

·      Strong skill set in interacting with multidisciplinary teams for preclinical and clinical development. Clear understanding of the drug development process with experience in multiple phases.

·      Experience with Orphan/Rare Disease programs, and/or Fast Track/Breakthrough Therapy is a plus.

·      Demonstrated leadership skills and ability to influence across all levels of a cross-functional team without direct managerial authority. Experience in risk assessment, negotiation, and problem solving/mitigation.

·      Outstanding interpersonal skills, ability to communicate effectively in both oral and written form, with effective time management skills needed to manage multiple ongoing projects simultaneously.

·      Demonstrated advanced computer software proficiency (Word, Excel, Smartsheet’s, PowerPoint, etc.).  

Physical Requirements:  

·      Ability to travel 20% of time

·      Ability to work in laboratory settings/situations

·      Prolonged periods sitting at a desk and working on a computer. 

·      Must be able to lift up to 15 pounds at times. 

Location:

This position is currently based in the Durham North Carolina area; Hybrid/ remote options considered.

 Salary Range:

$190,000-210,000

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. 

Opus Genetics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. 

Senior Director, Process Engineering & Contract Manufacturing Scale-Up

Location: Durham, NC (In-Office) 

Reports To: SVP Operations

Applying

To apply directly to this role, please email a non-ChatGPT paragraph explaining why you believe you would be the best fit for this role and attach your resume as a PDF. Applying via email is the only way to be considered.

About Carpe

Carpe is the fastest-growing deodorant brand in the United States. Our team is composed of ~25 incredibly smart people working together in person in downtown Durham, NC. Our office is open, collaborative, and high energy.

We build products that solve real problems for millions of people who struggle with excessive sweating. Our growth over the past several years has been rapid, and we are continuing to expand across retail, ecommerce, and new product categories.

As the company scales, building a strong, reliable, and scalable manufacturing foundation is critical to our long-term success.

The Role

We are seeking a high-ownership process engineering leader with a strong chemical engineering background who thrives in fast-growing environments and enjoys building systems that support scale. This is not a procurement or vendor management role. It is a technical manufacturing role focused on process engineering, scale-up, and improving manufacturing performance.

This role exists to build Carpe’s manufacturing process engineering capability as we expand production across multiple product categories and manufacturing partners. The primary focus is on developing robust, scalable processes that consistently deliver product performance.

This is a hands-on technical role. You will work directly with manufacturing teams to define critical process parameters, troubleshoot production challenges, and improve process reliability as we scale.

You will partner closely with Product Development, Operations, and Quality to translate product innovation into well-defined, scalable manufacturing processes. Success in this role requires the ability to develop long-term process engineering frameworks while also working directly with manufacturing teams to solve technical challenges and improve production performance.

What You’ll Do

Process Engineering & Manufacturing Science

• Build and lead Carpe’s internal manufacturing process engineering capability
• Work directly with contract manufacturing teams to document and refine production processes
• Identify and define critical process parameters that drive product consistency and performance
• Lead process characterization work, including DOE design and execution
• Improve process robustness and repeatability across manufacturing partners
• Troubleshoot complex manufacturing challenges and support manufacturing teams in solving production issues
• Drive continuous improvement initiatives across manufacturing operations

Technology Transfer & Product Scale-Up

• Lead the technical transfer of new products from development into commercial manufacturing
• Work directly with contract manufacturers to scale formulations and processes successfully
• Partner closely with Product Development to translate product specifications into scalable manufacturing processes
• Oversee pilot trials, validation runs, and commercialization readiness for new product launches
• Ensure new products are successfully and reliably launched across manufacturing partners

Manufacturing Performance & Continuous Improvement

• Establish operational metrics and performance tracking across contract manufacturing partners
• Improve manufacturing efficiency, yield, and process reliability
• Lead root cause investigations and corrective actions related to manufacturing issues
• Implement stronger process control and operational discipline across manufacturing partners
• Develop scalable manufacturing frameworks that support continued company growth

Cross-Functional Collaboration

• Partner closely with Product Development to ensure manufacturing processes support product performance requirements
• Collaborate with Quality and Regulatory to ensure manufacturing processes meet compliance and quality standards
• Work with supply chain and planning teams to support production scheduling and inventory needs
• Provide manufacturing insight during product development and innovation planning

Contract Manufacturing Leadership

• Own and manage Carpe’s network of contract manufacturing partners
• Build strong working relationships with technical teams at manufacturing partners
• Improve operational performance across quality, delivery, and cost
• Lead onboarding and qualification of new manufacturing partners as capacity expands
• Ensure manufacturing partners are prepared to support both current production and future growth
• Serve as the primary operational leader responsible for manufacturing performance across the network

Who You Are

• Bachelor’s degree in Chemical Engineering, Manufacturing Engineering, or a related technical discipline
• 10–15+ years of experience in manufacturing, process engineering, or operations leadership within consumer packaged goods, personal care, or related industries
• Experience with emulsions, OTC personal care, or topical formulation manufacturing
• Experience managing contract manufacturing networks and external production partners
• Strong technical background in manufacturing processes and scale-up
• Experience working with highly structured emulsions or shear-sensitive formulations
• Demonstrated ability to build systems, processes, and infrastructure in growing organizations
• Comfortable operating in fast-moving environments where both strategy and hands-on execution are required
• Willing and able to travel a lot (and last minute) 
• Strong engineering instincts and problem-solving ability
• Ability to work directly with manufacturing partners to improve processes and solve technical challenges

Bonus If You Have

• Background in manufacturing engineering or process engineering leadership roles
• Experience scaling products across multiple contract manufacturing sites
• Experience building manufacturing infrastructure in high-growth CPG environments

What You’ll Get

• Direct collaboration with senior leadership as we scale the business
• Opportunity to build and own Carpe’s manufacturing infrastructure during a major growth phase
• Competitive compensation based on experience and level
• Health, vision, and dental coverage
• Flexible PTO
• A front-row seat to the growth of one of the most disruptive brands in body care



Applying

To apply directly to this role, please email a non-ChatGPT paragraph explaining why you believe you would be the best fit for this role and attach your resume as a PDF. Applying via email is the only way to be considered.

Position Summary

The Senior Quality Assurance Specialist is responsible for the review, approval, and compliance oversight of GMP documentation supporting manufacturing operations and process validation activities. This role partners closely with Manufacturing Sciences & Technology (MS&T) and Manufacturing teams to ensure timely batch record, BOM, and technical document approvals while maintaining compliance with U.S. and EU cGMP regulations.

Key Responsibilities

• Review and approve GMP documentation supporting manufacturing operations, including Master Batch Records, Solution Records, Equipment Preparation Records, Process Assembly Records, Test Sampling Plans, and other manufacturing records as required.
• Collaborate with MS&T and Manufacturing to support BOM review, approval, and release within ASCTrac and SAP systems to ensure production timelines are met.
• Review and approve technical documents associated with process validation and manufacturing operations, including but not limited to:
• Process Characterization
• Process Performance Qualification (PPQ)
• Resin and Membrane Qualifications
• Non-routine Sample Plans
• Provide general QA support to manufacturing operations, including participation in deviation investigations, CAPA development, procedure reviews, and change control assessments, as required.
• Perform compliance review of executed batch records and internal support records to ensure adherence to cGMP and internal quality standards.
• Attend relevant project and operational meetings.
• Support client audits, client meetings, regulatory inspections, and process improvement initiatives as needed.

Qualifications:

• Bachelor’s degree with 10+ years of experience, or Master’s degree with 8+ years of experience, in a QA role within a cGMP-regulated biopharmaceutical (or equivalent) environment.
• Demonstrated experience supporting Manufacturing Process Operations and validation activities in a QA capacity.
• Strong knowledge of U.S. and EU cGMP regulations and guidelines.
• Working knowledge of electronic quality management systems and manufacturing execution systems.
• Working knowledge of electronical management systems
• Familiarity with Operational Excellence principles.

Gateway Building Company is a locally owned commercial general contractor serving the Triangle region. Our Durham-based team delivers commercial construction projects across interiors, healthcare, technology, industrial, and hospitality environments.

We specialize in mid-market commercial construction for owners who value professionalism, collaboration, and accountability. Gateway delivers the capability of a larger firm with the responsiveness and care of a smaller team, creating a better construction experience for our clients.

At Gateway, Project Managers do not just manage the work. They own it.

From preconstruction through closeout, our PMs serve as the single point of accountability for clients and trade partners. No handoffs. No confusion. Clear ownership from start to finish.

Our team brings decades of combined experience delivering complex commercial projects throughout the Triangle.

At Gateway, our Project Managers don’t just execute the work. They own it.

From preconstruction through closeout, our PMs serve as the single point of contact for clients and trade partners. No handoffs. No confusion. Just clear accountability from start to finish.

What Makes This Role Different

This is not a “stay in your lane” PM role. Our Project Managers are deeply involved in:

• Estimating and preconstruction planning
• Client leadership and communication
• Project execution and coordination
• Relationship management
• Supporting Gateway’s business development efforts by nurturing client relationships and helping grow future opportunities through exceptional project delivery

If you enjoy building trust with owners, brokers, architects, or developers and want to play a role in shaping the work that comes through the door, this role was built for you.

What You’ll Do

• Serve as the primary point of contact for clients from preconstruction through closeout
• Lead estimating efforts and provide conceptual through GMP-level cost development
• Partner with clients and design teams to align scope with budget goals
• Develop and manage project budgets, schedules, and contracts
• Lead coordination between project teams, subcontractors, and stakeholders
• Ensure quality, compliance, and risk management across all project phases
• Maintain strong relationships with clients and trade partners
• Contribute to future opportunities through trusted client relationships and exceptional project delivery

What You Bring

• 5+ years of commercial construction project management experience
• Experience managing projects up to $10M
• Strong estimating and preconstruction background
• Understanding of AIA contract structures and budget development
• Experience working in occupied or fast-track environments
• Ability to lead teams, maintain accountability of support staff, and keep momentum in a fast-paced environment
• Familiarity with Procore, Microsoft Project, or similar tools
• Existing relationships within the Triangle commercial construction market are strongly valued

How We Work

We bring our whole selves to work and value honesty over pretense. Happy clients are our business plan.

We believe in:

• Making it happen, not letting it happen
• Solving problems together
• Speaking up when something needs to be addressed
• Putting our clients first
• Supporting our community and contributing to sustainable growth

What We Offer

Competitive salary and performance-based bonus program, along with:

• 100% employee-paid medical, dental, and vision insurance
• company HSA contribution
• 4% annual 401(k) match

Gateway Building Company is an Equal Opportunity Employer. We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

For individuals with disabilities who would like to request an accommodation, please contact