Senior Quality Assurance Specialist

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 69 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 bachelors degree is preferred. Candidates with a masters 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 managers 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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