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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

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