Senior Quality Assurance Specialist

Integrated Resources, Inc ( IRI ); Cambridge (MA); In loco; USD 90.000 - 120.000; Tempo pieno

Descrizione del lavoro

Integrated Resources, Inc (IRI) is seeking a Pharmaceutical Quality Assurance professional to review event documentation, batch records, and regulatory filings. The role encompasses product disposition for drug substances, products, devices, and finished goods, and supports design verification and DHF deliverables.

The candidate will build and maintain PSF for client programs, demonstrate strong regulatory knowledge of FDA/EMA guidelines, and collaborate to ensure timely, compliant release in a

Competenze

• BS degree in life sciences, engineering or related field required.
• Minimum 5 years of pharma QA experience in GMP manufacturing/supply chain.
• Solid understanding of FDA and EMA regulations and guidelines.

Mansioni

• Review event documentation such as batch records, exceptions, and regulatory filings.
• Perform 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.

Conoscenze

Regulatory knowledge

GXP compliance

Teamwork and initiative

Independent prioritization

Communication skills

Problem solving

Organization skills

Attention to deadlines

Computer proficiency

Formazione

BS in life sciences/engineering

Strumenti

Microsoft Office

Descrizione del lavoro

• 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.