Job DescriptionYour RoleThe Sr. QA Specialist supports regulatory compliance and serves as a liaison between Quality, technical departments, clients, and applicable regulatory requirements. The role supports regulatory impact assessment and helps ensure regulatory commitments are integrated into site systems and client programs.
- Support regulatory submissions, registrations, licenses, regulatory commitments, correspondence, change-control impact assessments, and client regulatory requests.
- Assess proposed changes for potential regulatory impact and identify requirements for client approval, regulatory notification, filing, or other regulatory action.
- Support inspection readiness, client audits, regulatory inspections, regulatory document preparation, facility information requests, and responses to regulatory inquiries.
- Collaborate with QA - Quality Systems, Quality Engineering, Document Control, and applicable operational departments to ensure regulatory commitments are incorporated into controlled site systems.
- Maintain awareness of applicable regulatory requirements and communicate relevant changes or risks to Quality leadership and affected functions.
- May identify regulatory risks, recommend delay or hold of proposed changes pending regulatory assessment, and escalate regulatory concerns to Quality leadership.
Requirements- Bachelor's degree in Life Sciences, Engineering, Quality, or a related technical discipline.
- 6+ years experience in Quality Assurance within a pharmaceutical, biopharmaceutical, or other cGMP-regulated manufacturing environment.
- Experience supporting sterile and/or aseptic manufacturing operations.
- Strong knowledge of cGMP requirements and quality systems.
- Experience reviewing batch records and other GMP-controlled documentation.
- Experience with deviations, investigations, root cause analysis, CAPAs, change controls, and quality risk assessments.
- Familiarity with aseptic processing, APS/media fills, environmental monitoring, sterilization, and contamination control principles.
- Experience reviewing qualification and/or validation documentation.
- Ability to identify and escalate quality, compliance, and patient safety risks.
- Strong communication, documentation, problem-solving, and cross-functional collaboration skills.
- Ability to support regulatory and customer audits and inspection readiness activities.
BenefitsOffering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more
- 401(k) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Perks and Discounted Rates
- Financial Perks and Discounts
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