TI
Senior Quality Assurance Specialist
TalentBurst, Inc.
- 🇺🇸 United States
- On-site
- Senior
- 1 day ago
- $65 – $70 / hour
- GMP
- ICH
- GLP
- GxP
- Veeva
- Lean
- Smartsheet
1 day ago
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.
#Linkd
Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.
Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.
We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.
TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.
Senior Quality Assurance Specialist · TalentBurst, Inc.