Quality Assurance Associate II

Job Description

Duties and 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.

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.
• Preferred Quality Drug Substance manufacture experience.

Knowledge, Skills & Abilities:

• 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).
• 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.