Quality Assurance Specialist

Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary opportunity to work as a Quality Assurance Specialist - Biopharmaceuticals at a prestigious Fortune 500® company working in Sunnyvale, CA.

This is a 9+ month temporary position at 40 hours per week. 

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “submit now” button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position (keig126@kellyservices.com) however your resume must be received via the “submit now” button included within.

General Position Summary:
• Provide support in maintaining compliant, efficient internal quality systems and procedures related to the manufacture, packaging, testing, and disposition of drug substances and drug products at CMOs. Quality systems include, but are not limited to: Vendor Management, Audit Program, Quality Metrics, Management Review, Change Control, Investigations/CAPAs, and Validations while ensuring compliance with PCYC procedures, Policies, and cGMPs.

Key Accountabilities/Core Job Responsibilities:
• Responsible for QA related tasks in support of Quality Systems, including QA review and approval of documents and execution of transactions (Owner and/or QA Contact) in relevant GMP systems (Change Control, Deviation/CAPA, etc.).
• Support continuous improvement initiatives intended to increase Quality systems efficiencies within and external of the Quality organization. Operate as a liaison with the various technical, regulatory and Quality functions to ensure strategic alignment and compliance with PCYC and Quality System requirements
• Support other Quality System functions as assigned by Quality Management that are related to documentation creation/revision, Nonconformance review, Corrective and Preventative Actions, Risk Management, Training, product investigations, audits, and other tasks as directed
• Facilitate change management process by facilitating and collaborating with functional (Department) representatives the review and approval of proposed change and management of implementation activities to closure.
• Participate in management reviews. Prepare and present applicable quality metrics.
• Support and participate in regulatory inspections and internal audits.
• Support and participate in Quality investigations, as required.
• Supports the internal CMC team, as required.

Education and Training: (degrees, certifications)
• Bachelor’s Degree or equivalent professional experience B.A. or B.S. degree preferably in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing) or experience and training equivalent to such a degree.
• Four (4) or more year experience working in a cGMP regulated environment such as the field of quality assurance, quality control, and/or manufacturing operations, applying the cGMP rules in everyday activities. .
• Knowledge of pharmaceutical manufacturing process and FMEA Quality Risk Assessment knowledge.
• Hands on experience with quality systems in a GMP environment and experience with FDA and other health authority inspections

Specific Skills/Abilities:
• Excellent working knowledge of global GMP regulations, ICH guidelines and robust Quality Systems.
• Broad experience in the pharmaceutical industry with a strong analytical background.
• Detail oriented with demonstrated problem-solving acumen.
• Possess/demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
• Ability to work effectively in a team environment with great organization skills.
• Ability to independently analyze and reconcile complex issues.
• Must be an individual with proven initiative and accountability
• Must be able to work in a fast-paced environment.
• Excellent verbal and written communication and interpersonal skills.
• Proficient with Quality Management Systems such as Trackwise.

Why Kelly®?

Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity, and professionalism. Whether you seek the variety and flexibility of working on short-term project engagements or prefer contract-to-hire or direct-hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

Kelly complies with the requirements of the Fair Chance Initiative. A conviction record does not automatically bar individuals from employment.

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