Job Description

QA Training Specialist - Permanent - Philadelphia, PA

Proclinical are seeking a highly motivated individual for the position of Quality Assurance Training Specialist our Cell Therapy Center.

Primary Responsibilities:

This position is responsible for supporting the Quality Document Control program at the facility and ensuring compliance to quality objectives and regulatory requirements. In addition, this position will be responsible for providing training and guidance to users on our Electronic Document Management System (EDMS).

Skills & Requirements:

• Bachelor's degree in Life Sciences discipline preferred, not required.
• Experience training and documentation in pharmaceutical or biopharmaceutical GMP based facility.
• Familiar with document change management and FDA quality systems
• Familiar with an eDMS system (MasterControl is a plus)
• Must possess a high level of attention to detail and proficient in Word and Excel
• Strong computer, organizational, and compliance skills
• Ability to work effectively on multiple projects simultaneously with minimum supervision.
• Strong interpersonal and communication skills

The QA Training Specialist's responsibilities will be:

• Assist in the development and/or review developed training materials.
• Collaborate with Quality Assurance Document Control on training requirements impacting Document Change Control process.
• Supports training implementation in response to quality events
• Deliver training sessions, when applicable, and ensure training documentation is maintained. Ensure training schedules meet company production and quality targets.
• Assists functional groups with the creation or improvement of training content
• Continuously seek and support new approaches, practices and processes to improve the efficiency and efficacy of training.
• Adheres to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
• Supports documentation needs, which may include drafting and approval of SOPs, Work Instructions, Deviations, CAPAs, etc. Perform basic revisions as needed to accurately reflect current procedures.
• Attends meetings and escalates issues/concerns at that forum to Area Management for further investigation.
• May work on assignments that are moderately complex in nature, where judgment is required to resolve operational issues without negatively impacting manufacturing efforts.
• Ability to work in a team environment and independently as required.
• Contribute to department operations improvement in areas such as SOP revisions and department inspections.

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at [email protected]

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.

INDCQA

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