Senior Specialist II, Quality Assurance

Resilience is a technology‑focused biomanufacturing company dedicated to building a sustainable network of high‑tech, end‑to‑end manufacturing solutions. The Senior Specialist II, Quality Assurance (Blue Ash) provides technical and operational quality oversight across inspection, assembly, packaging, incoming quality control, and product release activities, ensuring compliance with cGMP, regulatory requirements, and internal quality standards.

Responsibilities

• Provide quality oversight for complex investigations, change controls, validation protocols, and technology transfer documents, ensuring adherence to specifications, procedures, and regulatory requirements.
• Review, approve, and manage validation documents including plans, URS, FS, SRA, SLIA, ACA, protocols, data analysis, discrepancies, and final reports.
• Act as SME and host during internal, regulatory, and customer audits and inspections, providing hands‑on support.
• Oversee manufacturing, laboratory, and quality system activities such as batch disposition, material sampling, investigations, deviations, CAPAs, change controls, risk assessments, and validation activities.
• Ensure cGMP compliance through documentation review, quality system monitoring, and support of inspection, assembly, packaging, testing, and release operations.
• Review and approve investigation impact assessments, collaborate on root‑cause analysis, resolve product quality issues, and drive corrective and preventive actions.
• Serve as the Quality representative and subject‑matter expert for cross‑functional projects, technology transfers, process improvements, audits, inspections, and regulatory interactions.
• Maintain quality documentation, records, procedures, specifications, validation documents, and quality metrics for accuracy and compliance.
• Support incoming material and component quality activities, including inspection, sampling, testing, and release decisions.
• Partner with Manufacturing, Technical Operations, Supply Chain, and Quality teams to ensure consistent execution of quality systems and uninterrupted product flow.
• Provide technical guidance, training, and direction to technicians and team members, fostering a culture of quality.
• Utilize quality and business systems (e.g., SAP, MAXIMO, CMMS, electronic QMS) for documentation, inventory management, data analysis, metrics reporting, and decision‑making.
• Collaborate with MSAT, Project Management, Engineering, and other departments to integrate new products and technologies into manufacturing.
• Assist in review and approval of new product introductions, ensuring quality standards throughout the product lifecycle.
• Lead risk assessments (e.g., pFMEA) and implement strategies to mitigate technical and quality risks.
• Train and mentor junior QA staff and provide QA coaching to non‑QA employees.

Minimum Qualifications

• Advanced technical expertise in equipment, utilities, facilities qualification, technology transfer, statistical analysis, investigation techniques, risk management, and process validation.
• In‑depth knowledge of industry best practices and regulatory guidance for technology transfer and validation; ability to apply guidance to novel situations.
• Proven ability to independently apply regulatory requirements (21 CFR 210, 211, 4, 820; ISO 13485, 14971; EMA, PDA, ICH, etc.) to complex compliance decisions.
• Knowledge of Design Controls and experience leading change management across multiple functions or sites.
• Leadership, relationship management, and organizational planning skills, including resource and timeline determination for quality deliverables.
• Experience serving as SME or host during customer audits and regulatory inspections, presenting and defending quality decisions.
• Experience leading risk assessments and applying risk management methodologies (FMEA, HACCP, LOPA, PHA, Lean tools, etc.).
• Expertise in quality management systems and designing/implementing new or improved QMS processes.
• Strong problem‑solving ability for complex technical, compliance, and business challenges in a fast‑paced environment.
• Excellent interpersonal, written, and verbal communication skills, including technical writing.
• Demonstrated ability to mentor and develop junior QA staff and coach non‑QA partners.
• Ability to travel 5‑10% based on project demand.
• Proficient with Microsoft Office (Word, Excel, PowerPoint, Outlook).

Preferred Qualifications

• Bachelor’s degree or higher in Pharmaceutical Sciences, Chemistry, Engineering, Life Sciences, or related field.
• Minimum 7 years of combined experience in quality assurance and/or validation within a GMP‑regulated pharmaceutical or biotechnology manufacturing environment.
• Direct experience with GMP regulatory requirements relevant to pharmaceutical manufacturing.
• Proven track record in technical troubleshooting and root‑cause analysis.
• Prior cGMP inspection, medical device assembly, and/or packaging manufacturing experience.
• Experience in a multi‑product facility and with sterile manufacturing processes.
• Working knowledge of cGXP requirements for manufacturing and inspection of pharmaceutical products.
• Previous experience supporting regulatory inspections and audits.

Schedule

8‑hour workday, Monday – Friday. Schedule may be modified based on business needs, operational requirements, or other considerations. No guarantee of specific hours, days, or shift assignments.

Physical Demands

• Sitting, standing, walking, bending, twisting, reaching, repetitive motion.
• Noise exposure, chemical usage.
• Monitoring other people's work.
• Wearing personal protective equipment (PPE).

Pay

Target base pay range: $90,000 – $123,750 per year. Actual base pay depends on geographic location, experience, qualifications, skills, and knowledge.

Benefits

• Annual cash bonus program.
• 401(k) plan with generous company match.
• Comprehensive healthcare (medical, dental, vision).
• Family‑building benefits.
• Life and disability insurance.
• Paid vacation and holidays.
• Other paid leaves of absence.
• Tuition reimbursement.
• Support for caregiving needs.