Quality Assurance Associate II

Industry: Pharmaceuticals

Title: Quality Assurance Associate II

Job ID: CAMB000111

Location: Cambridge MA (Hybrid)

Duration: 12 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 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