Quality Assurance Analyst

2 weeks ago

Akron, Ohio, United States TBA Full time

Position Overview:

The Quality Assurance Specialist is integral to the support of cGMP quality operations within Vector External Manufacturing. Key responsibilities encompass the examination of cGMP Controlled Documents, including Standard Operating Procedures (SOPs), specifications, completed batch records, and material disposition, while managing the implementation of necessary modifications to adhere to cGMP and internal standards. 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, with a focus on providing Quality oversight within a regulated cGMP environment.

Core Responsibilities:

The primary aim of the QA Specialist is to bolster routine clinical and commercial production, ensuring unwavering compliance with regulatory and industry standards. The role involves assisting the QA department in fostering a Quality-centric culture by guaranteeing that documentation is thorough, precise, and that batch records are executed in line with approved and effective SOPs and specifications.

Qualifications:


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


• 3-5 years of pertinent cGMP experience is essential, with a preference for experience in FDA/EMA regulations within biopharmaceuticals or cell therapy manufacturing.


• Practical experience in batch record review and product disposition is highly desirable.


• 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 expected.


• 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 Duties:


• Assess 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.


• Evaluate deviations, product non-conformities, and GMP investigations to ensure satisfactory resolution and adherence to current Good Manufacturing Practices (cGMPs).


• Potentially oversee department events and minor deviations.


• Facilitate the batch disposition process by ensuring all requisite documents are accurately and thoroughly completed, including all batch-related deviations.


• Review and endorse change control documentation that evaluates and defines the scope, impact, risk, and regulatory implications associated with changes.


• Review, manage, edit, and approve controlled documentation in compliance with cGMP standards.


• Coordinate and/or lead cross-functional meetings with various departments to drive the implementation of change controls.


• May assist in internal and external audits, including documenting observations and implementing corresponding Corrective and Preventive Actions (CAPAs).


• Lead small-scale projects as assigned.


• Update Standard Operating Procedures as necessary.


• May provide training and mentorship to junior team members.

Working Conditions:


• The role requires frequent standing, walking, sitting, bending, stretching, and using hands and fingers for various manipulations, as well as reaching with hands and arms, and effectively communicating with others in the workplace.

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