Job Details
Posted 23 October, 2026
Job Id: 631968
QA Sr. Specialist GMP
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 including design verification and DHF deliverables
*Build and maintain Product Specification Files (PSF) for the companies 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.
Pay ranges between 55-60/hr based on experience
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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