Job Description
Job DescriptionJob Title: Quality Assurance Associate II
Location: Cambridge, MA (Hybrid)
Duration: 12 Months
Job Description:
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 includeing design verification and DHF deliverables
- Build and maintain Product Specification Files (PSF) for Clients 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
- To have been involved on a device development project before as QA
- Signed off on design development plan, completed design verification, approved DHF deliverables
- Good understanding of FDA and EMA regulations and guidelines
- Excellent organizational, communication, and interpersonal skills.
- Preferred Quality Drug Substance manufacture experience
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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.
Company DescriptionFounded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website www.talentburst.com or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA
Company Description
Founded in 2002 by three former Monster.com executives; TalentBurst is an award-winning full-service Staffing Firm working directly with Fortune 500 companies in the US and Canada. We specialize in Contract and Contract to Permanent roles across many industries and have direct/contractual relationships with all our clients. Please visit our website www.talentburst.com or come meet us at our offices in Natick, MA, Miami, FL, Christiansburg, VA, Vineland, NJ, Houston, TX & downtown San Francisco, CA