Senior Quality Assurance Specialist

About the role

Location: Cambridge, MA 02142 (Onsite). Duration: 6-month contract with possibility of extension.

Responsibilities

• 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

Requirements

• 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)
• Minimum 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
• 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
• Six years of experience preferred as minimum; candidates with five exceptionally strong years of directly relevant experience may be considered
• Bachelor’s degree preferred; candidates with master’s degree or PhD 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 strength of relevant experience

Qualifications

• Veeva preferred; TrackWise or other QMS experience can help candidate ramp up quickly
• Basic Microsoft Office proficiency sufficient
• Smartsheet experience a plus (team maintains substantial content in the platform); basic proficiency sufficient
• Incumbent has been with team nearly five years and has covered many manager responsibilities during absences
• Ideal contractor will be trainable, highly collaborative, and able to get up to speed quickly with limited ramp-up time