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.
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 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.
Benefits
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.