What are the responsibilities and job description for the QA Associate V position at A&A Search Staffing LLC?
Quality Assurance Associate V - 6-month contract
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 the 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
Job Types: Full-time, Contract
Pay: $60.00 - $65.00 per hour
Schedule:
- Monday to Friday
Education:
- Bachelor's (Preferred)
Experience:
- pharmaceutical quality: 5 years (Preferred)
Work Location: One location