Information Technology For Development Jobs in Somerville

1,379 positions found — Page 73

IT Business Partner - GMP Manufacturing Operations
Salary not disclosed
Boston, MA 1 week ago

#2588 IT Business Partner - GMP Manufacturing Operations


Company and Role

Company is a publicly traded global pharmaceutical company with strong roots in the United States.



The IT Business Partner - GMP Manufacturing Operations will lead all technology implementation, production support, and maintenance activities within the Manufacturing Suite, ensuring systems are reliable, secure, and compliant with GMP and GxP requirements. This position will be responsible for authoring and enforcing SOPs to meet GMP guidelines, onboarding new equipment, maintaining compliance of existing systems, and driving the implementation of new IT GxP solutions such as Data Historian and LIMS.


Expectations

  • Own and foster the IT-to-business relationship for Manufacturing operations, ensuring alignment of technology strategy with manufacturing leadership priorities.
  • Define and manage a support and operating model for the Manufacturing Suite, maintaining application production environments to quality standards and delivering high-value implementation projects on time and on budget.
  • Lead a team of internal and external, onshore and offshore IT professionals to execute implementation and support activities, ensuring SLA adherence and customer satisfaction.
  • Provide oversight and expertise in Manufacturing change control, deviation management, and CAPA processes to ensure IT systems support regulatory and quality expectations; and proficient in tools like Veeva Vault, TrackWise Digital.
  • Work closely with the Process Automation (PA) group to define clear roles and responsibilities between IT and PA, ensuring seamless collaboration and system ownership across both functions.
  • Manage partner/vendor relationships, ensuring external service providers deliver quality and performance according to service levels and regulatory requirements.
  • Develop, write, and enforce Standard Operating Procedures (SOPs) to ensure adherence to GMP guidelines across all IT-supported manufacturing processes.
  • Oversee onboarding of new equipment into Manufacturing Suite, ensuring systems are validated, compliant, and maintained according to regulatory standards.
  • Maintain compliance of all existing equipment and IT systems, ensuring continuous alignment with GMP and GxP requirements.
  • Lead implementation of new IT GxP systems within the suite (e.g., Data Historian, MES, LIMS), ensuring proper validation, integration, and ongoing support.
  • Ensure adherence to regulatory requirements (FDA, GxP), cybersecurity standards, and departmental policies, practices, and SOPs.
  • Partner with global and local IT management to align best practices across Company, introducing process improvements and leveraging industry learnings.




Experience

  • Bachelor’s degree in computer science, Information Systems, Engineering, or related field.
  • Minimum of ten (10) years’ IT experience supporting pharmaceutical manufacturing suite or with at least 5 years in technical leadership roles.
  • Proven experience managing IT vendor relationships and service providers in a regulated environment.
  • Demonstrated expertise in GMP and GxP compliance, including authoring, maintaining, and enforcing SOPs for IT systems supporting manufacturing operations.
  • Demonstrated experience in configuring IT components for manufacturing equipment and writing user requirements
  • Strong background in equipment onboarding, validation, and lifecycle management to ensure systems remain compliant and audit-ready.


Preferred Experience

  • Hands-on experience with ERP, Data Historian, Laboratory Information Management Systems (LIMS), and other GxP manufacturing support technologies.
  • Hands -on experience: onboarding and installing pharmaceutical manufacturing equipment, configuring the systems for the equipment and writing the user requirements.


Benefits

  • Medical, Dental, Vision benefits
  • Short Term and Long Term Disability
  • Generous PTO, Holiday Schedule and Company Shut Downs
  • Annual Bonus Potential
  • Recipient of “Best Places To Work” multiple times for a positive corporate culture.
Not Specified
Sales Leadership & Sales Representative
Salary not disclosed
Boston, MA 1 week ago

Sales Leadership Roles – Focus On:

  • Building, mentoring, and leading a team of sales representatives and managers
  • Recruiting, interviewing, and developing quality individuals to join your agency
  • Conducting joint field work, orientations, and team meetings
  • Supporting business-to-business employee benefits sales activity
  • Building and maintaining strong relationships with business owners and HR professionals


Leadership Income Potential:

  • Agency Development Manager (ADM) Role: $40K–$120K+ based on production and recruiting performance
  • District General Agent (DGA) Role: $150K+ with growth opportunities and renewal income starting in year two


Sales Representative Role – Focus On:

  • Engaging with business owners and employees to provide benefit solutions
  • Supporting enrollments in core and voluntary benefits (accident, disability, life, and more)
  • Building long-term client relationships while driving new sales opportunities
  • Participating in ongoing training and professional development


Representative Income Potential:

  • Agency Sales Representative (ASR) Role: $50K–$80K+ based on production and recruiting performance
  • Uncapped commissions with renewal and bonus opportunities


Why Partner with Colonial Life

  • Backed by Unum Group, a Fortune 500 company
  • Trusted by 90,000+ client businesses and 4 million workers nationwide
  • Comprehensive voluntary benefits portfolio: Accident, Life, Disability, Cancer, Critical Illness, Dental, and Hospital Confinement
  • Personalized training and ongoing support through field classes, online courses, and home office instruction
  • The flexibility to be in business for yourself, but not by yourself


Recommended Experience and Skills

  • 1–3 years of B2B sales experience (helpful but not required)
  • Insurance sales or recruiting experience is a plus
  • Life & Accident/Health License (not required to apply, but must be willing to obtain)
  • Strong work ethic and self-motivation
  • Excellent communication and relationship-building skills
  • Ability to work independently or lead a team (depending on role)


This is an independent contractor opportunity in which you are in business for yourself, but not by yourself. Any income range represents potential earnings based on performance; it is not a guaranteed salary.


©2024 Colonial Life & Accident Insurance Company. All rights reserved.

Not Specified
Director of Quality
🏢 Sol-ti
Salary not disclosed
Boston, MA 1 week ago

Sol-ti’s success resides in consistently developing the highest quality Living Beverages backed by our Employee-Owned team that brings energy and excitement into their daily work with a passion for healthy living and sustainability.


Sol-ti means ‘of the sun’ or ‘you are the sun’. We are committed to helping individuals shine while also preserving the planet with the use of sustainable glass packaging.


Career Basics

Location: Boston, MA

Industry Type: Manufacturer

Category: Operations

Beverages: SuperFood Beverages, Wellness Shots, Functional Beverages

Employment Type: Full-Time

Reports to: VP Operations

Backup Role: Quality Supervisor

# of Direct Reports: 4

For this position, the candidate must reside in Massachusetts and be seeking a full-time position with onsite availability.


Position Summary:

The Director of Quality is a strategic and hands-on leader responsible for building and sustaining a culture where food safety, regulatory compliance, and product excellence are foundational to business performance. This role owns the end-to-end Quality function across internal manufacturing and external partners, ensuring the safe production of high-quality finished goods which meet Sol-ti’s standards for organic integrity, regulatory compliance, and operational excellence.

The Director of Quality develops people, systems, and processes to protect our consumers, strengthen our brand, and drive measurable business results. This leader establishes clear quality objectives, builds high-performing teams, defines and tracks KPIs, and partners cross-functionally to support innovation, growth, and continuous improvement.


Career Responsibilities:

  • Commit to following food safety policy, quality and regulatory requirements of FDA, USDA Organic NOP and SQF.
  • Drive a proactive Quality Culture through training, leadership development, and accountability systems.
  • Own and continuously improve Sol-ti’s Food Safety Plan, HACCP, Preventive Controls, and GMP compliance.
  • Lead and oversee all Quality Assurance and Quality Control programs across manufacturing, partner manufacturing, and suppliers.
  • Ensure compliance with FDA, USDA Organic, state, and international regulatory standards.
  • Serve as SQF Practitioner (or equivalent) and lead certification efforts and audits.
  • Serve as executive owner of recall readiness, crisis management, and regulatory response.
  • Lead root cause analysis and corrective/preventive actions (CAPA).
  • Define, track, and report quality KPIs across all manufacturing sites and partners.
  • Create and manage an external supplier quality program
  • Partner Manufacturing quality audits and performance management
  • Monitor regulatory trends and proactively adapt policies to evolving FDA, USDA, and applicable international standards.
  • Develop annual budget and ensure quality is fiscally responsible.
  • Packaging safety compliance (PFAS-free validation, glass integrity testing)
  • Oversee label compliance, claims substantiation, and regulatory review for new product launches
  • Partner with R&D and Operations to ensure quality integration throughout product development and commercialization.
  • Establish quality standards and validation protocols for new ingredient sourcing
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.


Career Requirements/What we ask of you:

  • 15+ years of quality experience in a manufacturing environment
  • Experience in the food and beverage industry preferred
  • Experience managing or overseeing third-party or co-manufacturing partners
  • Experience/Certifications required: SQFp (SQF Practitioner), PCQI (Preventative Controls Qualified Individual), HACCP, Internal Auditor, HAACP (Juice HAACP preferred)
  • Excellent verbal and written communication skills and organization skills.
  • Strong attention to detail with problem solving skills.
  • Ability to motivate team efforts to accomplish goals.
  • Some travel to other manufacturing partner sites


What we offer you:

  • $125,000-160,000 annually based on experience
  • Employee Equity Incentive Plan
  • Performance-based bonuses
  • Health Insurance programs with industry leading contributions towards your premium
  • Referral Programs and free access to our functional beverages and supplements to enjoy while at work or home
  • 80 hours of paid time off, two floating holidays and eight paid company holidays.


Sol-ti Values:

We each have an inner light. At Sol-ti, we encourage you to Let Yourself Shine while also encouraging others to shine their brightest. We are committed to helping individuals shine through Liquids of Vitality while also preserving the planet with the use of sustainable glass packaging.

Create the Best Product: Best in Glass

Did you know that most of the other beverages on the market use petroleum based single-use plastic packaging? Not only is this harmful to our oceans and landfills, it is also not sustainable. From the start, we have been committed to bottling in glass for purity, people, and the planet.

Our unique UV Light Filtration process uses light rays to preserve our liquid without pasteurizing it – eliminating spoilers without pasteurizing it – so you can enjoy organic, Glass Bottled, Living Beverages.

Not Specified
Entry Level Account Executive
Salary not disclosed
Woburn, MA 1 week ago

South Key is hiring for one of its clients! We are looking for a Entry Level AE to join our team in Woburn, MA. This position includes visiting business owners in designated territories.


Snapshot:

  • Train for a Full-cycle role: Prospecting to close
  • On-Target Earnings (OTE): $55-75k
  • Must be outgoing, have a good student mentality, and a strong work ethic



Key Responsibilities:

  • Develop and grow relationships with small business owners
  • Prospect new business in the field
  • Collaborate closely with leadership to position value to customers for all telecom and communication needs
  • Be part of an agile, growing team passionate about personal and professional development


What We're Looking For:

  • Strong communication and negotiation skills, with the ability to engage and influence decision-makers.
  • A passion for learning sales, business development, and team leadership
  • Familiarity with Salesforce, Google Suite, and Zoom.
  • A Bachelor's degree or equivalent work experience
Not Specified
Sales and Recruitment Consultant
🏢 SThree
Salary not disclosed
Boston, MA 1 week ago

We have an incredibly exciting opportunity for a Full Desk Recruitment Consultant to join the SThree team!


SThree is the only Global Staffing Company that focuses exclusively on STEM professionals.


We are looking for motivated, sales minded individuals who thrive in a competitive environment and are looking to grow their careers. Our award-winning training will be provided from day one and will set the stage for the opportunity to build your business and reputation within an exciting market.



As a Sales and Recruitment Consultant within our company, you will be responsible for:

  • Managing the candidate delivery of the recruitment life cycle
  • Business development of new and existing clients across industry verticals through meetings, networking, events and other sales techniques
  • Identifying the best candidates for niche job opportunities
  • Relationship building, writing advertisements, qualifying candidates, selling candidates on unique opportunities, pitching, and negotiating
  • Managing the candidate’s experience from submitting their resume to a client through post-placement check-ins
  • Closing candidates on job offers
  • Identifying and reaching out to potential new clients
  • Signing and Onboarding New Clients
  • Managing and expanding relationships with existing clients
  • Overseeing the onboarding process for recently hired candidates


Requirements

As a suitable applicant, you must be:

  • 6-months to 2yrs sales or new business development experience
  • Experience with cold- and warm-calling, pitching and negotiating
  • Motivated by success, financial gain, and career growth
  • Strong planning and organizational skills with a proven ability to effectively priorities multiple tasks
  • Effective communication skills
  • Excellent interpersonal and relationship building
  • Previous experience in a sales or customer-led environment
  • Previous experience of meeting business deadlines
  • Ambitious
  • Highly competitive
  • Resilient & Tenacious
  • Coachable and willing to implement feedback


Benefits

By starting a career with Specialist Staffing Group, you’ll have access to:

  • 17 days PTO, 12 Paid Holidays, and 2 Paid Floating Holidays
  • A hands-on training program from a dedicated Learning & Development department
  • A full-time base salary from day one plus uncapped commission: your earning potential truly is in your hands
  • A clear, merit-based career progression with fast-track opportunities into management
  • A robust D&I platform with numerous opportunities to get involved
  • Monthly incentives such as all expenses paid dinners at high-end restaurants
  • National and international incentive trips
  • New & modern offices located in the biggest and fastest-growing cities across the US
  • Medical, dental, vision, and 401k benefits



About Specialist Staffing Group (SThree)

Specialist Staffing Group (the US division of SThree) is the global leader in STEM recruitment. With over 45 offices across 15 countries and employing over 2,800 people, SThree operates across multiple brands that specialize in placing the best STEM talent around the world. You will be working with some of the biggest, most innovative, and most exciting companies in the world across as you progress and grow your career. Working in recruitment provides exciting career opportunities and high earning potential. In our Recruitment Consultant sales role you will be pitching to clients who are looking to attract and hire professionals with a niche STEM background.



If this is something you are interested in, please feel free to reach out to

Not Specified
Sales representative - Wound Care
Salary not disclosed
Boston, MA 1 week ago

Company Description

New Horizon Medical Solutions (NHMS) is a rapidly growing healthcare technology company specializing in biologics and advanced wound care solutions. By offering high-quality regenerative products alongside comprehensive practice optimization systems, NHMS empowers healthcare providers to deliver exceptional patient outcomes. The company focuses on innovative solutions that enhance clinical efficiency and support business growth for healthcare practices. NHMS is recognized for its commitment to improving healthcare delivery through cutting-edge technologies.


Role Description

This is a full-time remote role for a Sales Representative in Wound Care. The Sales Representative will be responsible for managing client relationships, presenting and selling advanced wound care solutions, and driving customer acquisition efforts. The role includes identifying potential clients, conducting product demonstrations, and collaborating with healthcare providers to meet their clinical and business needs. Additional responsibilities include building sales strategies and achieving set revenue and growth targets.


Qualifications

  • Proven experience in sales, client relationship management, and customer acquisition
  • Strong knowledge of healthcare or medical sales, particularly understanding of biologics and wound care solutions
  • Effective communication, presentation, and negotiation skills
  • Ability to set and achieve sales goals with a results-driven mindset
  • Self-starter capable of working independently in a remote environment
  • Proficiency in CRM tools, and other sales software
  • Previous experience in the healthcare industry or a related field is highly desirable
  • Bachelor’s degree in Business, Healthcare Management, or a related discipline is preferred but equivalent experience may be considered
Not Specified
Key Account Sales Executive
Salary not disclosed
Boston, MA 1 week ago

Our client is a U.S. based engineered manufacturing organization that designs and produces highly technical, build-to-print components for OEM customers across regulated and high-growth markets. The business is expanding vertically and is seeking a Key Account Sales Executive to lead account management and sales within this space on the east coast.


This is a true customer service role focused on the inside sales development of OEM accounts. The successful hire will maintain long-term relationships that move through engineering validation into recurring production programs. This role is heavily focused on account management and customer service rather than business development.


The role works closely with engineering and operations and is suited to someone comfortable navigating long, technical sales cycles within regulated environments.


Key Responsibilities:

  • Serve as the primary commercial point of contact for assigned OEM customers
  • Focus on equipment manufacturers within the industrial manufacturing space
  • Work closely with internal engineering teams once opportunities enter testing and development
  • Align customer outlooks with internal capacity and inventory planning
  • Manage complex sales cycles involving technical, quality, and commercial stakeholders


Compensation:

  • Competitive base salary with flexibility for the right candidate
  • Uncapped incentive plan aligned to opportunity creation and new business development
  • Long-term upside tied to conversion of opportunities into recurring production business


Required Skills:

  • Minimum of 3 years proven experience within customer service or account management
  • Background selling engineered components, materials, or build-to-print products
  • Comfortable with long sales cycles, validation processes, and technical buying groups
  • Strong account management and customer service skills
  • Able to engage credibly with engineering, quality, and operations stakeholders
Not Specified
Physical Therapist (1:1 Care Model - Brookline)
Salary not disclosed
Boston, MA 1 week ago

We Don’t Just Hire Therapists – We Develop Clinical Leaders Who Change Lives


Overview

At POST, every session matters. Our 40-minute, 1:1 treatment model gives you the time and autonomy to deliver truly transformational, evidence-based care (not transactional checklists). With structured mentorship, continuing education investment, and clear professional pathways, we’re committed to developing clinical leaders at every level.


POST Physical Therapy is expanding our high-performing clinical team, and we’re looking for a compassionate, motivated, and growth-minded Physical Therapist talent. If you’re passionate about helping people move better, feel stronger, and return to doing what they love, POST is where you can do your best work.


Our ideal teammate has strong orthopedic skills, delivers exceptional patient care, and thrives in a collaborative, fast-paced, learning-driven environment. You’ll design and deliver individualized care, guide patients through every phase of recovery, and make a measurable impact on their long-term health and performance.


If you’ve ever felt capable of more than your current role allows, POST offers the mentorship, support, and culture to elevate both your clinical career and the lives of your patients.


What You’ll Do

  • Deliver 1:1, 40-minute personalized care rooted in evidence-based practice
  • Create and progress individualized treatment plans tailored to long-term recovery and performance
  • Treat a diverse caseload including orthopedic, post-op, and sport-specific conditions
  • Track and celebrate patient progress through detailed assessments and documentation
  • Collaborate closely with fellow PTs, support staff, and referring providers for fully integrated care
  • Educate, empower, and motivate patients and families inside and outside the clinic
  • Contribute to our culture of innovation — including clinical projects, community events, digital content, and team development

What We’re Looking For

  • Doctor of Physical Therapy (DPT) or Master’s Degree from an accredited program
  • Valid Massachusetts PT license (or ability to obtain)
  • Experience in outpatient orthopedics strongly preferred
  • Strong clinical foundation in anatomy, physiology, manual therapy, and therapeutic exercise
  • Excellent communicator who can motivate, connect, and lead patients through the recovery journey
  • Independent, self-driven clinician who thrives in a collaborative, growth-oriented team
  • Commitment to contributing to a people-centered, positive, and ambitious clinic culture

Why POST? A Career - Not Just a Job


Clinical Excellence Is Our Standard

Our 40-minute one-on-one model, supported by the most up to date EMR and AI tools, ensures you have the time and bandwidth to deliver truly meaningful, high-quality care.


Clear & Supported Career Pathways

We invest heavily in clinician development with:

  • Structured mentorship at all levels
  • Continuing education reimbursement
  • Leadership tracks (clinical education, team lead, clinic partner roles)
  • Opportunities to specialize, teach, mentor, and lead

Whether you see yourself as a future specialist, educator, or partner, we help you grow toward your goals.

Sustainable, Balanced Workload


We believe great clinicians need balance to deliver great care. Our scheduling, productivity expectations, and team workflows are designed to support long-term excellence, not burnout.


A Culture You’ll Want to Be Part Of

POST is built on ownership, curiosity, collaboration, and raising the bar. Every teammate contributes to the outcome, every win feels shared, and everyone is committed to getting better together.


Compensation & Benefits

  • Full-time position with flexible scheduling options
  • Base Salary Range: $85,000+, commensurate with experience
  • Performance-based bonuses
  • Health and dental insurance
  • 401(k)
  • Continuing education reimbursement
  • Supportive team culture and high-growth environment

Location

In person – Our home base is located in Brookline, MA

(Additional locations coming soon as POST expands)


How to Apply

Send your resume to with “PT Position” in the subject line.


If you’re ready to grow your career in a place that values excellence, autonomy, and real impact — we’d love to meet you.

Not Specified
Senior Vice President Finance
Salary not disclosed
Boston, MA 1 week ago

Company Description

Passion Dental, formerly New England Family Dentistry, is a leading dental group providing extensive support and professional growth opportunities to general and specialty dentists, along with dental hygienists, in modern, state-of-the-art practices. The company operates with a commitment to safety, security, and ethical practices, ensuring high-quality dental care for all patients, regardless of financial or health literacy barriers. Established in 2006 by Dr. Patrick Assioun, the organization has grown to include practices in Massachusetts, New Hampshire, and Connecticut, offering comprehensive services in general dentistry as well as specialties like pediatric dentistry, orthodontics, endodontics, and oral surgery. Passion Dental upholds a mission to deliver evidence-based, comprehensive oral health care rooted in professionalism, safety, ethics, and clinical excellence.


Job Title: Senior Vice President, Finance

Company: Passion Dental

Reports To: President / CFO

Location: Onsight

Travel: As required to supported locations

Position Summary

The Senior Vice President of Finance (SVP Finance) is a key executive leader responsible for overseeing the financial health, strategy, and scalability of Passion Dental. This role provides strategic and operational financial leadership across a growing multi-location dental organization, ensuring strong fiscal controls, accurate reporting, disciplined capital allocation, and long-term value creation.

The SVP Finance partners closely with the President and CFO, executive leadership team, clinical leadership, and operational leaders to support growth initiatives, acquisitions, de novo expansion, and operational excellence while maintaining financial discipline and compliance.


Key ResponsibilitiesStrategic & Executive Leadership
  • Serve as a strategic advisor to the President / CEO and executive leadership team on financial planning, business performance, and growth strategy
  • Lead enterprise-wide financial strategy aligned with Passion Dental’s mission, values, and long-term objectives
  • Provide financial modeling and scenario planning to support acquisitions, expansions, and major investments
  • Present financial results, forecasts, and strategic insights to executive leadership and ownership
Financial Planning & Analysis (FP&A)
  • Oversee annual budgeting, long-range planning, and rolling forecasts
  • Develop and monitor KPIs to drive financial and operational performance across supported practices
  • Analyze practice-level and enterprise-level performance, identifying risks, opportunities, and improvement strategies
  • Ensure financial transparency and accountability across departments and locations
Accounting, Reporting & Controls
  • Oversee accounting operations, month-end close, financial reporting, and audit processes
  • Ensure compliance with GAAP, regulatory requirements, and internal controls
  • Maintain strong financial governance, policies, and procedures across the organization
  • Partner with external auditors, tax advisors, and financial institutions
Revenue Cycle & Cash Flow Management
  • Provide oversight and strategic direction for revenue cycle performance, including billing, collections, and payer mix optimization
  • Manage cash flow, working capital, and liquidity to support growth and operational needs
  • Optimize financial processes to improve efficiency, accuracy, and scalability
M&A, Growth & Capital Strategy
  • Lead financial due diligence, valuation, and integration planning for acquisitions and partnerships
  • Support de novo growth, construction, and capital projects through financial analysis and ROI modeling
  • Develop capital allocation strategies and financing structures to support expansion
  • Partner with operations and clinical leadership to ensure financially sound growth decisions
Team Leadership & Development
  • Build, lead, and mentor a high-performing finance, accounting, and FP&A team
  • Foster a culture of accountability, collaboration, and continuous improvement
  • Ensure systems, processes, and talent scale with organizational growth
QualificationsEducation & Experience
  • Bachelor’s degree in Finance, Accounting, or related field (MBA and/or CPA strongly preferred)
  • 12+ years of progressive financial leadership experience, including senior-level roles
  • Prior experience in healthcare services, dental support organizations (DSOs), multi-site operations, or private-equity-backed environments strongly preferred
Skills & Competencies
  • Strong strategic thinking with hands-on operational finance expertise
  • Deep understanding of financial modeling, forecasting, and performance management
  • Proven experience supporting growth, acquisitions, and complex organizational structures
  • Exceptional leadership, communication, and executive presence
  • Ability to translate financial data into actionable insights for non-financial leaders
  • High integrity, sound judgment, and a collaborative leadership style
Why Passion Dental

At Passion Dental, we believe financial leadership plays a critical role in supporting exceptional patient care, team member growth, and sustainable expansion. The SVP Finance will have a meaningful seat at the table, shaping the future of a rapidly growing organization committed to excellence, accountability, and innovation.

Not Specified
Quality Assurance Associate II
Salary not disclosed
Cambridge, MA 1 week ago

Industry: Pharmaceuticals

Title: Quality Assurance Associate II

Job ID: CAMB000111

Location: Cambridge MA (Hybrid)

Duration: 12 months contract (+Possibility of extension)


Duties

  • Review of event documentation such as Batch records, Exceptions, and Regulatory filings
  • Production record review and Product disposition for drug substance, drug product, device assembly and finished goods
  • Support design development plan including design verification and DHF deliverables
  • Build and maintain Product Specification Files (PSF) for Clients program


Skills

  • Knowledge of relevant government regulations and agency rules for labeling (CFR & EudraLex Volume 4, Annex 13)
  • Understanding of ICH, GLP, CGMP requirements, GXP regulations and current industry practices.
  • Demonstrated teamwork, initiative, and problem-solving skills
  • Ability to prioritize and work independently with minimal supervision
  • Ability to accurately determine deadlines and ask for help if needed
  • Detail oriented with solid problem solving acumen.
  • Ability to work effectively in a team environment with great organization skills.
  • Ability to independently analyze and reconcile moderate to complex issues.
  • Must have demonstrated initiative and accountability in a fast paced environment.
  • Excellent verbal and written communication and interpersonal skills.
  • Proficient with computers and word processing software (i.e., Microsoft Office products)


Education

  • Minimum, a BS degree in life sciences, engineering or related field
  • Minimum of 5 years pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environment
  • To have been involved on a device development project before as QA
  • Signed off on design development plan, completed design verification, approved DHF deliverables
  • Good understanding of FDA and EMA regulations and guidelines
  • Excellent organizational, communication, and interpersonal skills.
  • Preferred Quality Drug Substance manufacture experience
Not Specified
jobs by JobLookup
✓ All jobs loaded