Quality Assurance Analyst

2 weeks ago

Akron, Ohio, United States TBA Full time

Position Overview:

The Quality Assurance Specialist is integral to ensuring the compliance of 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 pivotal in facilitating the release of vector timelines post-manufacture and supports all activities related to routine clinical and commercial product releases, emphasizing a Quality perspective in a regulated cGMP environment.

Core Responsibilities:

The primary objective of the QA Specialist is to uphold compliance with regulatory and industry standards during routine clinical and commercial production. This includes:

  • Assisting the QA department in fostering a quality-centric culture by ensuring documentation is thorough and batch records are completed in alignment with approved procedures.
  • Reviewing executed batch records to confirm adherence to established procedures and addressing discrepancies with manufacturing personnel.
  • Providing Quality support during GMP events and leading deviation investigations.
  • Evaluating deviations, product non-conformities, and GMP investigations to ensure compliance with current Good Manufacturing Practices (cGMPs).
  • Supporting the batch disposition process by verifying that all necessary documents are accurately completed, including batch-related deviations.
  • Reviewing and approving change control documentation, assessing the scope, impact, risk, and regulatory implications of changes.
  • Coordinating and leading cross-functional meetings to facilitate change control implementation.
  • Participating in internal and external audits, documenting observations, and implementing corrective actions as necessary.
  • Leading small-scale projects as assigned and revising Standard Operating Procedures as required.
  • Mentoring and training junior team members.

Qualifications:

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

Experience:

  • 3-5 years of relevant cGMP experience, particularly in FDA/EMA regulations within biopharmaceuticals or cell therapy manufacturing.
  • Hands-on experience with batch record review and product disposition is advantageous.
  • Proficient in computer applications such as Word and Excel, along with other electronic manufacturing systems.
  • A detail-oriented team player with strong planning, organizational, time management, and execution skills.
  • Demonstrated ability to work collaboratively within teams to achieve collective goals.
  • Strong critical thinking skills to evaluate information and determine appropriate actions.
  • Ability to thrive in a fast-paced team environment.
  • Excellent written and verbal communication skills.

Working Conditions:

While performing the duties of this position, the employee is frequently required to stand, walk, sit, bend, stretch, and use hands and fingers for various tasks. Effective communication with others in the workplace is essential.

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