Quality Assurance Analyst

2 weeks ago

Akron, Ohio, United States TBA Full time

Position Overview:

The Quality Assurance Specialist is integral to the cGMP quality operations within Vector External Manufacturing. Key responsibilities encompass the evaluation of cGMP Controlled Documents, including Standard Operating Procedures (SOPs), specifications, completed batch records, and material disposition. This role is essential in managing the implementation of necessary changes to adhere to cGMP and internal standards, directly supporting the release of vector timelines from the manufacturing date.

The QA Specialist primarily focuses on facilitating routine clinical and commercial production, ensuring adherence to regulatory and industry standards. This position aids the QA department in fostering a quality-centric culture by verifying that documentation is thorough, precise, and that batch records are executed in line with approved and effective SOPs and specifications.

Qualifications and Skills:

Education: A Bachelor's degree in a relevant scientific or engineering field is preferred, with a minimum of an Associate's degree required.

Experience:

  • 3-5 years of pertinent cGMP experience, with a preference for familiarity with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
  • Practical experience in batch record review and product disposition is advantageous.
  • Proficient computer skills, particularly in Word, Excel, and other electronic manufacturing systems.
  • A detail-oriented team player with strong planning, organizational, time management, and execution capabilities.
  • Demonstrated experience in collaborative team environments where collective contribution and results are emphasized.
  • Ability to exercise sound judgment and critically evaluate information to determine the appropriate course of action.
  • Capacity to thrive in a fast-paced team setting.
  • Excellent written and verbal communication skills.

Key Responsibilities:

  • Review executed batch records to confirm compliance with approved procedures, addressing and resolving discrepancies with manufacturing personnel.
  • Provide Quality support and direction during GMP events and the initiation of deviation investigations.
  • Assess deviations, product non-conformities, and GMP investigations to ensure satisfactory resolution and compliance with current Good Manufacturing Practices (cGMPs).
  • May oversee department events and minor deviations.
  • Support the batch disposition process by ensuring all required documents are accurately completed, including all batch-related deviations.
  • Review and approve change control documentation that evaluates the scope, impact, risk, and regulatory implications associated with changes.
  • Review, manage, edit, and approve controlled documentation in accordance with cGMP standards.
  • Coordinate and/or lead cross-functional meetings with various departments to facilitate change control implementation.
  • May assist in internal and external audits, including documenting observations and implementing corresponding Corrective and Preventive Actions (CAPAs).
  • Lead small-scale projects as assigned.
  • Revise Standard Operating Procedures as necessary.
  • May provide training and mentorship to junior team members.

Working Conditions:

While performing the duties of this role, the employee is frequently required to stand, walk, sit, bend, stretch, use hands and fingers for various manipulations, reach with hands and arms, and effectively communicate with others in the workplace.

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