Senior QA Specialist

PSC Biotech; Nebraska; Vor Ort; USD 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Medical, Dental, and Vision - PSC pays

Insurance options for EAP, Life, STD/L

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

Zusammenfassung

PSC Biotech is seeking a Senior QA Specialist to provide QA oversight of sterile and aseptic manufacturing operations, ensuring cGMP compliance and GMP documentation control. You will review batch records, lead investigations, and support change controls and risk assessments across cross-functional teams.

You will collaborate closely with Manufacturing, Quality Control, Engineering and Validation, driving continuous improvement and inspection readiness.

Qualifikationen

• 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 elevate 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.

Aufgaben

• Provide QA oversight of sterile and aseptic manufacturing operations to ensure compliance with cGMP requirements, approved procedures, and quality standards.
• Review and approve batch records and GMP documentation in support of product quality and disposition activities.
• Lead and review deviations, investigations, root cause analyses, CAPAs, and effectiveness checks.
• Review and approve change controls, quality risk assessments, and qualification and validation documentation.
• Provide QA oversight for aseptic processing, APS/media fills, environmental monitoring, sterilization, and contamination control activities.
• Identify, assess, and escalate quality, compliance, and patient safety risks.
• Provide GMP and quality guidance to cross-functional teams.
• Support customer and regulatory audits, inspection readiness activities, and continuous improvement initiatives.
• Collaborate with Manufacturing, Quality Control, Engineering, Validation, and other functions to address quality and compliance needs.

Kenntnisse

QA oversight

cGMP knowledge

Documentation

Problem-solving

Ausbildung

Bachelor's degree

Life Sciences

Engineering

Quality

Jobbeschreibung

BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and compounding, fill-finish, and lyophilization services for a wide variety of liquid injectables. BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.

BioTechnique utilizes our team’s expertise to create a process design for our clients’ products that best suits their needs.

The Experience

With operations spanning the globe and featuring a multi-cultural team, BioTechnique is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered a compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At BioTechnique, it’s about more than just a job—it’s about your career and your future.

Your Role

The Senior QA Specialist provides Quality Assurance oversight and guidance for sterile and aseptic manufacturing operations, ensuring compliance with cGMP requirements, approved procedures, and established quality standards. This role supports product quality and disposition activities through the review and approval of GMP documentation, investigations, CAPAs, change controls, risk assessments, and qualification/validation documentation. The Senior QA Specialist partners cross-functionally with Manufacturing, Quality Control, Engineering, Validation, and other teams to identify and mitigate quality and compliance risks while supporting inspection readiness and continuous improvement.

• Provide QA oversight of sterile and aseptic manufacturing operations to ensure compliance with cGMP requirements, approved procedures, and quality standards.
• Review and approve batch records and GMP documentation in support of product quality and disposition activities.
• Lead and review deviations, investigations, root cause analyses, CAPAs, and effectiveness checks.
• Review and approve change controls, quality risk assessments, and qualification and validation documentation.
• Provide QA oversight for aseptic processing, APS/media fills, environmental monitoring, sterilization, and contamination control activities.
• Identify, assess, and esc... risk related to product quality, patient safety, and regulatory compliance.
• Provide appropriate GMP and quality guidance to cross-functional teams.
• Support customer and regulatory audits, inspection readiness activities, and continuous improvement initiatives.
• Collaborate with Manufacturing, Quality Control, Engineering, Validation, and other functions to address quality and compliance needs.

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 elevate 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.

Offering 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

Equal Opportunity Employment Statement

BioTechnique is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.