Kelly Services Quality Assurance Auditor in Fremont, California
QA Specialist Drug Product/Quality Assurance Auditor, Fremont
Date Start: 12/04/2018 - Date End: 12/04/2019
Works independently to provide quality assurance oversight of any area assigned where the business is responsible for adhering to current Good Manufacturing Practices cGMPs including aseptic knowledge, drug product processing, visual inspection, syringe and vial filling, labeling and packaging, batch record review, critical utilities, e.g. WFI, Steam, Automation, equipment, HVAC, etc. warehouse, new product introduction/product transfer, external quality and laboratories.
Demonstrates a high level of independent judgment and discretion in the timely identification, investigation and resolution of events impacting the Quality of products and processes.
Quality oversight responsibilities include ensuring adherence to SOPs and requirements, proper change control, corrective action and preventive action plans CAPA /Deviation management, impact assessments for changes to equipment and processes, risk management, and ensuring documentation and investigations meet all requirements. With autonomy and authority, makes difficult decisions with little time for deliberation which may have a direct impact on active manufacturing operations, the release of equipment, systems, or areas.
Provides guidance and mentorship to junior staff regarding decision making processes and process expertise with high-level quality oversight to ensure compliance with cGMP s, regulatory, industry, and corporate requirements.
Responsible for executing QA operations and overseeing junior team members as they assess, evaluate, and review operations on the floor as defined above against cGMPs to assure real-time observation of activities, issue identification/ resolution including proper and timely documentation. Provides guidance to MFG, E T, and/or QC to ensure compliance with all applicable regulations and assists in resolution of issues identified. Information must be pro-actively shared across QA and the business including the on-going training of junior team members.
Identifies, classifies and reports deviations, as appropriate and typically works on more complex Minor and/or Major deviations. Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with others to determine root cause and potential preventative/corrective actions.
Ensures support for the timely closure of investigations.
Authorized to suspend any operation when the situation warrants.
Provides guidance and control directives regarding remediation activities required to continue production. Is required to resolve critical issues within area assigned and may escalate to senior management team based on severity of the issue.
Responsible for providing quality oversight to the change management system for complex Minor and/or Major classified Change Controls. This includes providing plan creation oversight, verifying that changes adhere to local SOPs and regulatory compliance and ensuring communication/escalation of potential issues of broader impact to the business.
Performs independent technical review of documentation during and post-execution of cGMP activities.
Has authority to sign off/qualify/train junior staff on QA Operation responsibilities.
Requires a Bachelor’s degree, from an accredited institution, in Microbiology, Biology, Chemistry (or closely related degree with these core courses as the foundation)
Five (5) to seven (7) years of quality assurance experience in the pharmaceutical industry providing oversight to Manufacturing Operations, QC, and other cGMP areas.
Excellent attention to detail, i.e. labeled drug product
Project management experience
Strong independent judgment and decision making abilities required.
Strong knowledge of relevant regulatory guidances.
Demonstrated problem-detection and problem-resolution skills required.
Strong conflict resolution and negotiation skills required.
Must possess demonstrated organizational skills that have proven results in the ability to be self-directed while managing multiple projects.
Must possess excellent verbal and written communication skills; good interpersonal skills.
Mentoring experience required.
Physical Demands / Surroundings - The duties of this position may require the incumbent to exert some physical effort. Lifting requirements may vary dependent of the QA area assigned. Weight is typically no more than 25 pounds. Work environment is dependent upon the area assigned. For example, Plant QA requires full gowning and gloving certification,
Visual Demand s - Must be able to read and see clearly. Employees assigned to Visual Inspection Drug Product will be required to participate and have acceptable results from vision testing including color -blindness.
Temperaments/Mental Requirements - Frequently required to exercise judgment and make decisions. Probable errors might cause moderately serious delays, confusion, and could affect company reputation/customer relations or expense to correct.
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AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.