Jobs in Somerville

Quality Control Consultant

6 Month Contract (Potential to be extended)

Hourly Range – $80-90/hr (depending on experience)

Location: Remote (East Coast Preferred)

Scientific Search has partnered with a growing publicly traded Pharmaceutical Company who has tasked us in finding a QC Consultant. This position will report into the Head of QC and work remotely anywhere on the East Coast.

Qualified candidates should have thorough knowledge of stability, deep experience with QC investigations, and experience working for smaller biotech companies focused on small molecule drug development.

Responsibilities

• Oversees Quality Control testing of small molecule therapeutics in clinical development through commercial stage, including late-stage product specification setting and stability program oversight.
• CoA generation and approval
• Collaborates cross-functionally and with external partners to ensure that quality control processes are aligned to the ensuring fit for purpose analytical methods, compliance, and alignment with business needs.
• Accountable for QC OOS/OOT investigations
• Investigates, identifies root cause, and identifies CAPA for testing deviations.
• Authors monitoring and trend reports in support product release and stability.
• Directly manage reference standard and reference material program for assigned products; includes authoring and reviewing associated protocols and reports.
• Along with Analytical Development and Technical Operations, provides input for analytical and microbial method development and testing, technical services and commercial supply support to ensure timely testing. Ensure method transfer and phase appropriate qualification/validation of analytical methods as well as the transfer and validation of methods between testing sites.
• Support QC Systems development, implementation and improvement in accordance with the requirements of cGMP.
• Authors, reviews, or approves SOPs, qualification/validation protocols and reports and change controls as related to Quality Control.
• Supports the establishment and publishing of Key Performance Indicators to track cGMP compliance for the Quality Control function. Captures metric information for use in continuous improvement of areas of responsibility.
• Participates in audits of the laboratories.
  
  

Qualifications

• Master’s Degree and 5+ years’ experience OR Bachelor’s degree with 10+ years of experience.
• QC lab management experience.
• Thorough knowledge of Stability.
• Experience setting specifications and product expirations.
• Deep experience with QC OOS/OOT investigations
• Well versed in various analytical and bioanalytical techniques for small molecule therapeutics
• Working knowledge of quality systems, US regulatory requirements (21 CRF Part 11/210/211,820), and Guidance documents.
• Working knowledge of analytical method validation and methods transfer
• Thorough knowledge of GMPs/cGMPs, SOPs and quality control processes
• Thorough knowledge of technical writing for NDA, BLA, IND, CMC sections.
• Experience with equipment qualification and validation.
• Knowledge of data management tools and statistical process control, and data integrity requirements and expectations.
• Experience with ELN and LIMS desirable.
• Proficient in MS Word, Excel, Power Point and other applications
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities.
• Demonstrated expertise in commercial manufacture.
• Ability to communicate and work in a self-guided manner with internal and external scientific/technical personnel, and all other cross-functions.
• Comfortable in an adaptable small company environment with minimal direction and able to adjust workload based upon changing priorities.
  
  

How To Apply

We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to and tell me why you’re interested. Or, feel free to email your resume. Please include Job#19761.

- REMOTE

Registered Nurse Residency Career Opportunity

Encompass Health: Where Nursing Meets Heart, Home, and Healing
Looking for a nursing career rooted in purpose, close to your heart and home? At Encompass Health, you'll play a vital role in patients' recoveries-providing individualized, compassionate care that makes a lasting impact. Here, small victories add up to monumental change, and you'll thrive in an environment built on support, advanced resources, and teamwork.

For new graduates or nurses with less than one year of experience, our 9-month Nurse Residency Program offers structured guidance and added support as you begin your career in rehabilitation nursing. With extended orientation, interdisciplinary shadowing, focused education, and an evidence-based project, the program sets you up for long-term success.

Encompass Health is where nursing becomes more than a job-it's a meaningful contribution to your patients, your community, and yourself.

A Glimpse into Our World
At Encompass Health, you'll experience the difference the moment you become a part of our team. Being at Encompass Health means aligning with a rapidly growing national inpatient rehabilitation leader. We take pride in the growth opportunities we offer and how our team unites for the greater good of our patients. Our achievements include being named one of the "World's Most Admired Companies" and receiving the Fortune 100 Best Companies to Work For® Award, among other accolades, which is nothing short of amazing.

Starting Perks and Benefits
Our benefits are designed to support your well-being and start on day one:

• Affordable medical, dental, and vision plans for both full-time and part-time employees and their families.
• Generous paid time off that accrues over time.
• Opportunities for tuition reimbursement and continuous education.
• Company-matching 401(k) and employee stock purchase plans.
• Flexible spending and health savings accounts.
• A vibrant community of individuals passionate about the work they do!

Realize Your Vision as a New Registered Nurse

• Join a supportive RN cohort with a structured curriculum designed to build confidence, enhance your skills, provide mentorship and set you up for long-term success.
• Build meaningful relationships with patients and their families, understanding their unique needs to facilitate their recovery.
• Collaborate and communicate effectively with various departments to ensure coordinated care and provide direct patient care when needed.
• Celebrate victories and milestones achieved by our patients.

Qualifications

• Valid RN licensures as required by state regulations.
• CPR certification (ACLS preferred).

The Encompass Health Way We proudly set the standard in care by leading with empathy, doing what's right, focusing on the positive, and standing stronger together. Encompass Health is a trusted leader in post-acute care with over 150 nationwide locations and a team of 36,000 exceptional individuals and growing! At Encompass Health, we celebrate and welcome diversity in our inclusive culture. We provide equal employment opportunities regardless of race, ethnicity, gender, sexual orientation, gender identity or expression, religion, national origin, color, creed, age, mental or physical disability, or any other protected classification.

DCS has an exciting opportunity for a Cybersecurity support to ensure that all system and application deliverables meet the requirements of all DoD and Air Force cybersecurity policies as identified in the following paragraphs.

The applicant shall ensure that all system deliverables comply with DoD and Air Force cybersecurity policy, specifically DoDI 8500.01, Cybersecurity, and that application deliverables are complaint with Public Law 111-383, which states the general need for software assurance.

Essential Job Functions: To ensure that cybersecurity policy is implemented correctly on systems, the applicant shall ensure compliance with DoD and Air Force certification and accreditation policies, specifically Department of Defense Instruction (DoDI) 8510.01, Risk Management Framework (RMF) for DoD Information Technology.

The applicant shall ensure that all application deliverables comply with DISA Application Security Development Security Technical Implementation Guide (STIG), which includes the need for source code scanning to mitigate vulnerabilities associated with SQL injections, cross-site scripting and buffer overflows.

The applicant shall support activities and meet the requirements of DoDI 8520.02, Public Key Infrastructure (PKI) and Public Key (PK) Enabling, in order to achieve standardized, PKI- supported capabilities for biometrics, digital signatures, encryption, identification and authentication.

The applicant shall be able to perform work that involves ensuring the confidentiality, integrity, and availability of systems, networks, and data through the planning, analysis, development, implementation, maintenance, and enhancement of information systems security programs, policies, procedures, and tools.

The applicant shall travel as required to support cybersecurity assessments or cybersecurity incidents.

The applicant shall ensure personnel performing cybersecurity activities obtain and remain current with technical and/or management certifications to ensure compliance as directed by DoD 8140.02, Identification, Tracking, and Reporting of Cyberspace Workforce Requirements, and outlined in DoD 8570.01-M, Department of Defense Computer Network Defense (CND) Service Provider Certification and Accreditation Program, Appendix 3, Table 1.

Responsibilities may include but are not limited to: Assist with development of System Security Management Plans, Program Protection Plans, Security Risk Analyses, OPSEC Plans, Computer Certification and Accreditation, Security Vulnerability and Countermeasures Analyses, Security Concepts of Operations, and other system security engineering-related documents identified in MIL-STD 1785, DoDI 5000.02, Operation of the Adaptive Acquisition Framework, and DoDI 8510.01.

Support the system/application Authorization and Accreditation (A&A) effort to include assessing and guiding the quality and completeness of A&A activities, tasks and resulting artifacts mandated by governing DoD and Air Force policies (i.e., Risk Management Framework (RMF).

Update, monitor, and manage information in systems for the program office.

Process and manage system user account requests and process tools.

Process and manage system port/protocol and access control list requirements.

Process and manage system Public Key Infrastructure (PKI) identification and authorization requirements.

Manage the distribution, implementation, remediation, and tracking of system security updates and configurations as required by the DoD.

Recommend policies and procedures to ensure information systems reliability and accessibility to prevent and defend against unauthorized access to systems, networks, and data.

Conduct risk and vulnerability assessments of planned and installed information systems to identify vulnerabilities, risk, and protection needs.

Promote awareness of security issues among management and ensuring sound security principles are reflected in organizations’ vision and goals.

Conduct systems security evaluations, audits and reviews.

Recommend systems security contingency plans and disaster recovery procedures.

Recommend and implementing programs to ensure that systems, network, and data users are aware of, understand, and adhere to systems security policies and procedures.

Participate in network and systems design to ensure implementation of appropriate systems security policies.

Recommend initial, or updates to, software and configurations to new or existing system security mechanisms.

Obtain waivers to mandated security mechanisms/policies which would be detrimental to system performance and impact the system’s mission.

Facilitate the gathering, analysis and preservation of evidence used in the prosecution of computer.

Provide leadership assistance in the analysis of the design, development, integration, implementation and testing of cybersecurity requirements.

Develop risk-based strategies to address identified gaps.

Review, analysize, and assess implementations of cybersecurity (i.e.

RMF security controls) throughout the open systems architecture and associated services, derived requirements specifications, design documents & design implementation.

Collaborate with stakeholders (Government and commercial) to ensure the system is approved by all Authorizing Officials via the RMF A&A process.

Provide technical advice in the area of systems security across all systems and supports.

Develop recommendations for the Government regarding how well designs satisfy current requirements and business goals.

Maintain databases that reflect receipt, storage, inventory, and disposition of classified information to include data entry, updates, and generation of reports.

Support Government program office in audits of Government classified holdings to ensure proper accountability.

Maintain databases of classified visits and clearance levels.

Perform inspection, inventory, logging, storage, documentation, transmittal and internal distribution of classified information received.

Evaluate applicant classified data submittals for compliance with the appropriate System Security Classification Guide (SSCG).

Provide security inspection and protection to areas where classified information is being stored, and develop and establish security procedures and policies IAW DOD, USAF, AFMC, and local directives.

Required Skills: Due to the sensitivity of customer related requirements, U.S.

Citizenship is required.

A High School Diploma plus 20 years of experience, an Associate plus 14 years, a bachelor's degree plus 512years or a master's degree plus 10 years of experience.

An adjudicated DoD Secret Security clearance on the First Day of employment.

CISSP Certification required.

Understanding of cybersecurity in DoD cloud infrastructure.

Understanding of Agile methods, including CI/CD, DevSecOps, and DevOps.

Possess the ability to effectively communicate in both written and verbal forms on highly technical topics.

Salary Range: $87,934-$120,000 At DCS, we pride ourselves on providing flexibility that allows employees to balance meaningful work with their personal lives.

We offer competitive compensation, benefits, and opportunities for learning and development.

Our broad and competitive mix of benefits is designed to support and protect employees and their families.

Our robust benefit offerings include medical, dental, 401k, ESOP, PTO, education reimbursement, work/life balance, parental and other leave programs.

Learn more about our benefits here: DCS Corp Benefits

DCS has an exciting opportunity for a Senior Program Manager providing support to the Air Force Life Cycle Management Center/Electronic Systems (AFLCMC/HB).

The Air Force Program Execution Office for PEO Digital (AFPEO/HB) has the collective Air Force Materiel Command (AFMC) mission responsibility to manage and execute the modernization, development, testing, production, fielding, and sustainment of the PEO Electronic Systems portfolio, which includes over 130 programs for the United States Air Force (USAF) and foreign allies.

AFLCMC/PEO Electronic Systems is headquartered at Hanscom Air Force Base, MA with geographically separated operating units CONUS and OCONUS.

This is a full-time position located at Hanscom Air Force Base, MA.

Essential Job Functions: Acquisition and Program Support: Provide program-level acquisition support to Program Managers and Integrated Product Team Leads, guiding program execution to meet cost, schedule, and performance objectives.

Ensure adherence to DoD directives and policies, including DoDI 5000.02, DoDI 5000.80, and DoDI 5000.81.

Contract Execution and Oversight: Support contract execution through expert analysis and solutions, including reviewing acquisition documents, milestone decision briefings, and risk management plans.

Prepare inputs for RFPs such as system specifications, SOWs, and CDRLs.

Program Health Analysis: Evaluate program health, advise leadership on options to maintain objectives, and assist in planning acquisition strategies that align with DoD and Air Force policies.

Documentation and Reporting: Develop and maintain acquisition reports (e.g., MAR, DAES, APB), prepare briefings, and ensure consistency across program deliverables.

Utilize tools such as CCaR, IDECS, and EDA.

Risk Management: Develop, maintain, and execute program risk management plans, facilitating risk identification, analysis, and mitigation while coordinating program risk boards and working groups.

Source Selection and Contract Administration: Assist in developing source selection strategies, evaluation criteria, and RFP documentation.

Provide recommendations for incentive clauses and evaluate contractor proposals.

Mission Planning and Operational Support: Oversee Mission Planning Environment (MPE) systems to ensure they meet operational and testing requirements.

Coordinate with stakeholders to align MPE capabilities with operational flight program schedules.

Lifecycle Logistics and Sustainment: Provide critical support for lifecycle logistics, operational planning, and sustainment strategies, ensuring mission readiness and effective system integration.

Policy and Process Improvement: Monitor DoD acquisition reforms and advise leadership on process improvements, cost avoidance strategies, and policy interpretations.

Ensure compliance with updated regulations and directives.

Stakeholder Engagement: Collaborate with division branch chiefs, program managers, and contractors to provide expert guidance, streamline integration, and address programmatic issues affecting overall performance.

Required Skills: Due to the sensitivity of customer related requirements, U.S.

Citizenship is required.

Must have and be able to maintain an active Secret level clearance.

Bachelor’s degree in a professional engineering discipline from an ABET-accredited program, and minimum of 12 years of experience in the respective technical/professional discipline, including at least 5 years supporting DoD programs.

Requirements development, production and deployment, and operations and support.

Architecture development and implementation.

Modeling and simulation, including Model-Based Systems Engineering principles.

Verification and validation processes.

Technical data package development and sustainment.

Principles of configuration management.

Network architectures, embedded systems, and application deployment across various systems and hardware, including cloud deployment and virtualization.

Desired Skills: Master’s degree in a professional engineering discipline from an ABET-accredited program.

Salary Range: $87,934-$120,000 At DCS, we pride ourselves on providing flexibility that allows employees to balance meaningful work with their personal lives.

We offer competitive compensation, benefits, and opportunities for learning and development.

Our broad and competitive mix of benefits is designed to support and protect employees and their families.

Our robust benefit offerings include medical, dental, 401k, ESOP, PTO, education reimbursement, work/life balance, parental and other leave programs.

Learn more about our benefits here: DCS Corp Benefits

DCS has an exciting opportunity for a Senior Systems Engineer providing support to the Air Force Life Cycle Management Center/PEO Digital Directorate (AFLCMC/HB), filling a full time position located at Hanscom Air Force Base, Bedford, Massachusetts.

Essential Job Functions: The candidate will provide Systems Engineering assistance that applies a broad theoretical and practical knowledge of system engineering to the acquisition process.

The candidate will also provide engineering support in the design, operation, and sustainment of systems and components that cover tasks throughout the acquisition life cycle (requirements analysis through system disposal).

Conduct reviews on program portfolio to evaluate and/or recommend alternative plans, improve systems engineering programs/processes, manage/sustain program technical baseline, and design/perform system level tests to assure that subsystems and system performance is achieved in accordance with approved specifications.

Perform program reviews to evaluate alternative proposed plans, systems engineering programs, design and test results to assure that subsystem and system performance is achieved in accordance with program specifications.

Prepare technical documents which define, specify, and recommend system/subsystem characteristics.

Prepares management reports and conducts technical presentations for planning, implementation and corrective action using application of engineering economy principles.

Perform validation of systems, including development of criteria and procedures.

Analyze and/or evaluate results of major engineering systems.

Provide system/program engineering, technical support and technical training to support programs/initiatives, including but not limited to: acquisition, development, integration, sustainment, continued evolution, deployment/fielding and installation, and operations oversight.

Provide engineering support services and inputs to program and project risk management activities in compliance with AF SEAM processes.

Provide engineering support to conduct formal trade studies based on engineering performance, effectiveness, cost effectiveness, cost performance, life cycle cost, productivity, reliability, maintainability, risk, and schedule.

Provide technical recommendation support services, including reviews, studies, audits, evaluations and analyses, scientific and procedural guidance, documentation, technical analysis, and support of associated engineering IPTs.

Provide proposal analysis support services that compare and quantify proposed systems, components, approaches for technical feasibility, compatibility, and cost effectiveness.

Provide concepts and requirements analyses support services including, but not limited to, reviewing and analyzing.

Review and analyze system concepts and user requirements that have been approved and entered into a system requirements baseline (functional, allocated, and product).

Assist with material solution analysis, technology, engineering, and manufacturing development, production and deployment, and operation and support.

Support engineering technical and technical management processes associated with version/configuration control.

Requirements definition and analysis.

Architecture design, implementation, integration, verification, validation, transition, decision analysis, technical planning, technical assessment.

Requirements management, risk management, configuration management, technical data management, and interface management.

Assist with planning and execution of technical reviews and assessments (e.g.

System Requirements Review, Technology Readiness Assessment), as well as associated documentation development (e.g.

Systems Engineering Plan, Risk Management Plan) that are an inherent part of the activities and processes listed above.

Development of systems engineering documentation, an understanding of the linking interactions between systems of systems, configuration management, technical data packages and acquisition and sustainment engineering processes.

Support engineering technical and technical management processes associated with version/configuration control, to include: a) Requirements definition and analysis; b) Architecture design, implementation, integration, verification, validation, transition, decision analysis, technical planning, technical assessment; c) Requirements management, risk management, configuration management, technical data management, and interface management.

Assist with planning and execution of technical reviews and assessments (e.g.

System Requirements Review, Technology Readiness Assessment), as well as associated documentation development (e.g.

Systems Engineering Plan, Risk Management Plan) that are an inherent part of the activities and processes listed above.

The Contractor shall provide engineering support in the design, operation, and sustainment of systems and components that cover tasks throughout the acquisition life cycle (requirements analysis through system disposal).

Tasks may also include supporting Foreign Military Sales.

Conduct and support all engineering and technical activities required during the material solution analysis, technology, engineering, and manufacturing development, production and deployment, and operation and support phases of the systems acquisition process.

Develop/prepare engineering and technical documentation inherently part of the activities listed above (e.g.

Analysis of Alternatives (AoA), Systems Engineering Plan (SEP)…), systems review and analysis with written reporting, briefing, and artifact development as required for all of the technical specialty areas defined in this section; and the planning and execution of all necessary technical reviews, assessments, and interchange meetings (e.g.

Critical Design Review(CDR), Manufacturing Readiness Assessment (MRA), Reliability Technical Interchange Meeting (TIM)) and associated artifacts (e.g.

Critical Design Review entry and exit criteria).

Conduct systems architectural analyses to include system design/design feasibility and state-of-the-art assessment.

Produce architectures, document planned and existing systems, determine deficiencies, develop alternatives, recommend solutions, and support development of a plan to implement the chosen solution per acquisition and sustainment system engineering processes.

This may include traditional architecture development or Model Based Systems Engineering processes.

Track and ensure system architecture and interoperability requirements for the baselined system is maintained.

Detail operational requirements and functional interactions within the system and with other systems, considering life cycle costs, logistics supportability, human factors, et al, to determine if the basic building blocks of the system are defined in sufficient detail to support a development program effort.

Translate DoD user requirements into system requirements for designing, developing, testing and evaluating systems and subsystems using USAF and DoD approved acquisition methods.

Provide engineering analysis of system training, training equipment and simulator requirements; prepare technical documentation; and provide engineering evaluation of equipment and simulator designs.

Understand and implement robust DoD acquisition and sustainment systems engineering processes to address the life-cycle requirements.

Prepare and review program specifications for items, processes and materials.

Develop and utilize analytical, simulation, MBSE and digital engineering analysis techniques to optimize system performance and/or system effectiveness; establish system sensitivities, define system parameters, evaluate hardware and validate flight test results in terms of overall system relationships and applications.

Develop, prepare, review, and integrate selected milestone review documentation, periodic reports, and certifications as identified in current DoD and AF acquisition policy.

Review, evaluate and monitor acquisition Contractor drawings for completeness, currency, technical accuracy and conformance to requirements, specifications, regulations and quality control to ensure compliance with ASME technical Data Package format and requirements.

Complete and support requirements definition and analysis, architecture design, implementation, integration, verification and validation, transition, decision analysis, requirements management, risk management, interface management, and configuration management.

Facilitate the transfer of information, lessons learned and best practices across all customers and contractors serviced under this task order within constraints of proprietary rights.

Perform market research and trade studies to assess current and future systems to ensure they that meet mission needs/requirements.

Conduct, define and evaluate system cost, schedule, and technical performance.

Perform reviews, studies (including root cause analysis), audits, evaluations and analyses and provide technical recommendations to the Government.

Conduct engineering performance, effectiveness, cost effectiveness, cost performance, life cycle cost, producibility, reliability and maintainability, risk and scheduling trade-off studies.

Develop USAF approved Test and Evaluation Master Plans (TEMP), test plans and procedures, prepare test readiness reviews and associated test documentation using DoD and USAF standard processes, execute developmental tests and assist in operational test planning/execution, and evaluate tests in support of acquisition and sustainment programs.

Participate in integrated logistics support efforts, provisioning and source coding, maintenance data collection, technical order management, configuration management, evaluation of quality deficiency reports, and/or identification of alternate sources of supply for diminishing manufacturing/materiel sources preferred.

Required Skills: Due to the sensitivity of customer related requirements, U.S.

Citizenship is required.

A bachelor’s degree in a related field and 10 years of experience, 5 of which must be in the DoD.

Active Secret security clearance.

Experienced in requirements development, production and deployment, and operation and support, architectures development & implementation, modeling & simulation including but not limited to Model Based Systems Engineering principles, verification & validation, technical data package development and sustainment, and principles of configuration management.

Experience with network architectures, embedded systems and application deployment across a variety of systems and hardware, to include cloud deployment and virtualization.

Familiarity with DoD Acquisition processes including Technology Maturation, Risk Reduction, Engineering Manufacturing and Development, Production and Deployment activities.

Familiarity with Electronic Warfare and/or Air Combat operations including live aircrew training/development of tactics, techniques, and procedures and Range Infrastructure architectures and systems.

Salary Range: $87,934-$130,000 At DCS, we pride ourselves on providing flexibility that allows employees to balance meaningful work with their personal lives.

We offer competitive compensation, benefits, and opportunities for learning and development.

Our broad and competitive mix of benefits is designed to support and protect employees and their families.

Our robust benefit offerings include medical, dental, 401k, ESOP, PTO, education reimbursement, work/life balance, parental and other leave programs.

Learn more about our benefits here: DCS Corp Benefits