What are the responsibilities and job description for the Quality Assurance Manager position at Proclinical Staffing?
Quality Assurance Manager - Contract - Cranbury NJ
Join the team as a Quality Assurance Manager and play a key role in maintaining top-tier quality standards! If you have a keen eye for detail and a passion for compliance, this could be your perfect opportunity.
Primary Responsibilities:
The successful candidate will be required to support our viral vector drug substance manufacturing and testing facility. You will play a crucial role in ensuring compliance with quality standards and regulatory requirements while enhancing quality systems and processes. This position offers the chance to contribute to a dynamic team focused on advancing gene therapies for rare childhood diseases.
Skills & Requirements:
- Degree in biological sciences or related field; advanced degree preferred.
- Experience in biological sciences or biotechnology, particularly in cell and gene therapy.
- Knowledge of cGMPs and international regulations for drug manufacturing.
- Ability to work collaboratively in a fast-paced environment.
The Quality Assurance Manager's responsibilities will be:
- Support the transition from phase-appropriate to commercial GMP activities.
- Conduct product release activities, including batch record reviews.
- Assess and approve analytical documents such as validation protocols and stability data.
- Evaluate change controls for process and product impact.
- Act as QA reviewer/approver for development reports and product specifications.
- Identify and escalate critical compliance and quality assurance issues.
- Assist in preparation for FDA and other regulatory inspections.
- Review raw data for internal reports and regulatory submissions.
- Collaborate with experts to improve processes and procedures.
- Approve SOPs, specifications, and controlled documents.
- Track and trend deviations and corrective actions.
- Coordinate Annual Product Quality Reviews and other summaries.
- Support internal audits and risk assessments.
If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at j.cerchio@proclinical.com
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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