Quality Assurance Specialist (Lynchburg, VA)
We are looking for an QA Specialist to be responsible for providing compliance support within our Quality Assurance Department that executes and maintains tasks such as: Site Change Control Program, Stability Program, Supplier Quality and Auditing, Internal Auditing, Investigations, Complaint Investigations, Annual Product Reviews, Calibration Review, Work Order Review, QA support for New Product Development, SOP review and approval, and support for Audits and Regulatory Inspections.
WHAT YOU’LL DO
- Compliance to cGMPs and Fleet’s SOPs and other procedures and assigned Quality functions.
- Provide guidance to change control owners in all GMP areas to ensure compliance with all procedures.
- Provide oversight of the Non-Conformance program for OTC and cosmetic products. Prepare annual schedules, review protocols, data, and reports. Support maintenance of equipment.
- Provide QA support to Product Development and Analytical Development departments during the development of new products
- Complete complex and critical manufacturing, packaging, material, testing, and complaint investigations utilizing root cause analysis tools and technical writing skills to document findings, corrective, and preventive actions, and recommend disposition.
- Perform root cause analysis with team members and subject matter experts to identify corrective and preventive action plans. Recommend disposition of product based on investigation findings
- Conduct peer review investigations and reports for accuracy, completeness, and conformance to SOPs
- Perform approval of minor investigations when deemed appropriate
- Participate in Inspection Readiness activities and support audits and Regulatory Inspections. Lead with strong verbal and written communication skills during audit situations.
- Review and approve complaint investigations
- Provide oversight and support the process for calibration and work order review
- Provide monthly reports on time for key performance indicators
- Support continuous improvement projects
- Perform other related duties as required.
EDUCATION AND EXPERIENCE, YOU WILL BRING
- Requires the knowledge gained through a bachelor’s degree in technical or science related field and three years of experience in a GMP environment OR work experience equivalent to a minimum of ten years of experience in a GMP environment
WHAT WE OFFER
Fleet is part of Prestige Consumer Healthcare, a major player in over-the-counter personal healthcare products with over $1 billion in sales. You may come for the job, but what you’ll get is the opportunity to grow it into a great career. Here are some other things to consider…
You will be able to use and grow your talents by helping assure only the highest quality in the development and manufacture of wide portfolio our iconic branded products. The work is fascinating and challenging. We have top notch health/welfare benefits and an FSA savings plans too. We provide a solid company match on your 401(k) contribution that vests 100% immediately. We have a consistent record of paying good bonuses. We offer unlimited and free access to learning opportunities through LinkedIn Learning and other trainings.
Connect with us at: www.prestigebrands.com
Prestige is an Equal Opportunity Employer
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