Associate III, Quality Assurance
Job Location:
Durham County, NC - USA
Monthly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
About This Role
As a QA Associate III you will apply strong knowledge of cGMP requirements Biogen Quality Systems internalproceduresand your primary quality discipline to support compliant manufacturing operations. You will review and approve documentation that supports batch and cell bank disposition assess product acceptability for continued processing or distribution and providetimelyquality direction on the manufacturing floor. You will partner across Quality Manufacturing and PO&T toidentifyand resolve quality and compliance concerns support inspection readiness and advance new product introduction technology transfers and restart programs. You will also provide technical writing and investigation support including root cause and impact assessments and may complete selected minor investigation or GCC assessment activities afterdemonstratingthe required competencies and with management oversight. This individual contributor role requires sound judgment mature situationalleadershipand the ability to work independently while collaborating across functions and organizational levels.
WhatYoullDo
Review and approve batch and cell bank disposition documentation for cGMP compliance and product acceptability
Review executed BPRs PRCDs/WIs formulas recipes validity rules MPRs MSLRs MSMs PCDs PFDs and PARs
Perform manufacturing-floor record review observations WORCs and inspection-readiness walkthroughs
Provide quality oversight of manufacturing operations and technical consultation on regulatory and site-procedure requirements
Support resolution of technical and compliance issues or gaps of low to moderate complexity
Support the QA Lead for NPI technology transfers and restart programs
Provide technical writing investigation support root causeanalysisand impact assessment
Support CAPA closure and review or approval of associated documentation with management oversight
Assistwith implementation of Quality Management Systems andGxPquality-systems training
Communicate quality issues recommendations and decisions across Quality ManufacturingEngineering Warehouseand other functions
Who You Are
You are a detail-oriented quality professional who applies sound judgment regulatoryknowledgeand a practical understanding of manufacturing to protect product quality. You communicate complex information clearly adapt to changingprioritiesand build productive cross-functional partnerships to resolve issues andmaintaincompliance.
Required Skills
Bachelors Degree preferred in a life science discipline
2 years of related experience working in a quality GMP biopharma or pharma environment
Working knowledge ofGxPregulations cGMPrequirementsand relevant FDA/EMA expectations
Understanding of quality systems qualityconceptsand manufacturing processes
Strong organizationprioritizationand multi-tasking skills
Excellent writtenverbaland interpersonal communication skills
Preferred Skills
Investigation root cause analysis impactassessmentand technical writing skills includingdemonstratedcompetency in minor investigations CAPA documentation or GCC assessments
Experience reviewing controlled manufacturing and disposition documentation
Understanding of biopharma or pharma manufacturing processes
Additional Information
Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.
Regular employees are eligible to receive both short term and long-term incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.
In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social well-being; including but not limited to:
- Medical Dental Vision & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10000 per calendar year
- Employee Resource Groups participation
Why Biogen
We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our Biogen.
All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.
Required Experience:
IC
About Company
Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patientsÂ’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities, ... View more
