Senior Specialist, Quality Systems
About The Position
The Senior Quality Systems Specialist provides quality systems and operational expertise for the Forge GMP facility in Grove City, OH. The Quality Systems Specialist will provide expertise and guidance in authoring, reviewing, and approving quality events such as deviations, CAPAs, change controls, and investigations. The Quality Systems Specialist will also be responsible for monitoring and improving the internal quality systems policies and workflows at Forge. Prior experience/specialized skills may result in additional responsibilities and/or development opportunities. The Sr. Quality Systems Specialist must demonstrate accountability, transparency, and effective communication cross-functionally and within the Quality team.
Requirements
- Bachelor’s Degree (B.A. or B.S.) in biological or STEM-related field (or equivalent work experience)
- Strong expertise in deviation management processes including in-depth root cause analysis and CAPA implementation.
- Thorough knowledge and application of Good Documentation Practices (GDP).
- Experience in a GxP environment.
- Must be self-motivated, organized, and proactive.
- Demonstrated knowledge and understanding of cGMP regulations and Food and Drug Administration (FDA) and EU requirements/guidance documents.
- Ability to maintain a high degree of attention to detail.
- Ability to deliver results in a fast-paced, multi-tasking environment, and prioritize objectives effectively.
Nice To Haves
- Experience with root cause analysis and investigations, including technical writing skills.
- Working knowledge of global pharmacopeias such as USP, EP, JP, BP, Ph. Eur.
- Knowledge of biopharmaceutical manufacturing process workflows.
- Experience supporting inspections performed by FDA and foreign Regulatory Authorities.
- Experience within a pharmaceutical, biotech, or related industry.
- Sterile injectable pharmaceuticals or biologics experience is preferred.
- Experience with Veeva Vault QMS.
Responsibilities
- Serve as a quality resource for quality system principles, including documentation control, change control, deviations, CAPAs, and investigations.
- Proactively identify and implement items to enhance quality through continuous improvement (CAPA).
- Make fact-based, scientifically and/or statistically sound, quality / regulatory compliant decisions that have impact on product release.
- Author or review and approve investigations, CAPAs and change controls to drive for resolution through root cause analysis.
- Author or review and approve controlled documentation including Standard Operating Procedures (SOPs), Work Instructions, and Forms.
- Work with other technical groups to resolve issues, close gaps and seek quality compliant outcomes which are efficient and robust.
- Support internal and external audits as needed.
Benefits
- Health, dental and vision insurance start your first day – with 90% of premiums covered for you and your family.
- A competitive paid time off plan
- 12 weeks of fully paid parental leave
- Annual bonus opportunities for all full-time team members.
- 401(k) with company match
- Special employee discounts, including childcare and dependent care savings.
- Onsite fitness facility at The Hearth.
- Mental health counseling and financial planning services through our Employee Assistance Program.
- Employer-paid short and long-term disability coverage
- A fully stocked kitchen with free snacks and beverages
- Ongoing professional development resources, training, and mentorship programs
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What This Job Offers
Job Type
Full-time
Career Level
Senior
