Senior Quality Assurance Specialist

Six years of experience is preferred as the minimum; candidates with five exceptionally strong years of directly relevant experience may be considered. • Production record review and Product disposition for drug substance, drug product, device assembly and finished goods.

Title: Sr. QA Specialist GMP
Location: Cambridge MA 02142 (Onsite)
Duration: 06 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 client 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
•            Good understanding of FDA and EMA regulations and guidelines
•            Excellent organizational, communication, and interpersonal skills.
 
Ideal Candidate Profile
Core Experience & Skills
•            Strong quality dispositioning experience; ideally 6–9 years of relevant experience.
•            QMS proficiency, preferably Veeva; experience with TrackWise or another QMS is also relevant.
•            Exception management experience.
•            Experience with temperature excursions and Veeva Tasks is valuable.
•            Ability to initiate and manage files in Veeva.
•            A Lean mindset and a collaborative approach, including working with Clinical Supply Chain.
•            Strong verbal and written communication skills.
 
Experience & Education
•            Six years of experience is preferred as the minimum; candidates with five exceptionally strong years of directly relevant experience may be considered.
•            A bachelor’s degree is preferred. Candidates with a master’s degree or PhD are welcome.
•            Scientific educational background should not be an automatic screening barrier; dispositioning experience is the primary priority.
•            Candidates with an associate degree may be considered based on the strength of their relevant experience.
 
Tools & Technologies
•            Veeva is preferred; TrackWise or other QMS experience can help a candidate ramp up quickly.
•            Basic Microsoft Office proficiency is sufficient.
•            Smartsheet experience is a plus because the team maintains substantial content in the platform; basic proficiency is sufficient.
 
Team Fit & Ramp-Up Expectations
•            The incumbent has been with the team for nearly five years and has been able to cover many of the manager’s responsibilities during absences.
•            The ideal contractor will be trainable, highly collaborative, and able to get up to speed quickly and work with limited ramp-up time.

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