QA Associate III
Location : Ramsey NJ US 07446
Job Type : Direct
Reference Code : 20372-AB1
Compensation : 75000.00 - 95000.00 USD/YEAR
Start Date : 12/07/2020
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Biology, Microbiology or related science.
Travel : No
Relocation : No
Job Industry : Pharmaceutical
Job Description :
- Permanent position for a QA Associate III responsible for Quality Assurance activities with minimal supervision to support Quality Systems and client procedures.
- Responsible for document management, issuance, review and approval of batch records, SOPs, and Qualification and Validation Reports.
- Responsible for review of QC data, performing material releases and final product releases, and review of Deviations.
- Manage internal and external audits with regulatory agencies and clients.
- Provides resolutions pertaining to quality for project related issues.
- Independently prioritize, schedule, and manage multiple projects and resources.
- Ensure safe release of cellular products in accordance with company procedures and client requirements.
- Ensure compliance with applicable cGMP and cGTP regulations and company and client SOPs.
- Author and review relevant SOPs, validation and other documents.
- Responsible for the timely issuance, review and approval of QC certificates, closure of Batch Records, and deviation reports.
- Master Batch Record Control, distribution and label verification.
- Assignment and maintenance of product Lot numbers as applicable.
- Perform internal documentation audits as assigned.
- Materials management nonconformance disposition and release activity as applicable.
- Evaluate and investigate deviation reports,
- Initiate and coordinate corrective and preventive actions.
- Track and trend relevant quality metrics including environmental monitoring data.
- Provide Quality Assurance related support to various departments.
- Interface with suppliers and in-house production personnel to ensure effective CAPAs are implemented for recurring product and process discrepancies.
- Provide training to personnel as assigned by supervisor.
- Some travel may be required.
Required Qualifications :
- BS Biology or related science.
- Minimum 5 years experience in QA in a pharmaceutical or biotech manufacturing facility.
- Experience in manufacturing and testing of biologics with technical understanding of aseptic manufacture of biologics.
- Experience in both clinical and commercial manufacturing is preferred.
- Experience in authoring, reviewing, and approving cGMP / cGTP related documents (validation / qualification reports, SOPs).
- Knowledge and experience on quality systems and procedures and cGMP / cGTP issues.
- Experience in organizing teams for effective and timely completion of projects.
- Experience in electronic applications for training, deviations, CAPA management, etc.
- Experience participating in or hosting health authority inspections and client audits.
- Detail-oriented, analytical and problem-solving skills, and strong project management and organization skills.
- Must have interpersonal skills to work in a team-oriented environment and with clients.
- Organization skills, multi-tasking skills, good verbal and written communication skills, computer skills, and training abilities.
Contact: Allan Berman