Senior Associate I, Quality Assurance (On The Floor, Swing Shift)

Biogen•Research Triangle Park, NC

7d•$81,000 - $105,000•Onsite

About The Position

This is a full time, on-site position with a schedule of 12 noon to 12 midnight on a rotating 2-2-3 schedule About This Role The QA Sr Associate I has the working understanding, full knowledge and ability in their primary discipline. They are able to apply technical principles, concepts and understanding of systems and procedures in order to conduct quality and compliance related activities. They are proficient in their understanding of the Biogen Quality Systems. The QA Sr Associate I has working knowledge of GxP regulations and adheres to all regulatory licenses and regulations as well as internal SOPs. The Associate identifies and resolves issues through collaboration with others. They partner with colleagues in identifying and resolving potential compliance concerns. The QA Sr Associate I performs all duties in a manner consistent with site and corporate policies, cGMP, safety, environmental and human resources policies and procedures. The Associate should be able to work effectively, independently and within a team framework, across multiple business areas and levels of the organization.

Requirements

Bachelor’s Degree required in life sciences or related (or Associate's Degree plus 6 years of experience)
Minimum of 4 years of experience working in a GMP pharma or biotech manufacturing environment
Must have experience working in QA on the floor/shop floor
Ability to work effectively, both independently and within a team framework across all business areas and levels within the organization locally and globally
Excellent written, verbal, and interpersonal communication skills
Familiarity with downstream process manufacturing

Nice To Haves

Previous relevant industry experience in a GMP manufacturing environment
Experience with column packing or reviewing column pack binders

Responsibilities

Ensure disposition documentation and other documents supporting batch and cell bank disposition are compliant and determine acceptability for use in cGMP production activities and/or release of product for further processing and/or distribution. This includes but is not limited to Review and Approval of executed BPRs, PRCDs/WIs, Formulas, Recipes, Validity Rules (FRRV/BOM), existing/revised MPRs, MSLRs, MSMs, PCDs, PFDs, PARs; on the Manufacturing floor record review and observations, performing WORCs, performing inspection readiness walkthroughs, and oversight of Manufacturing operations.
Supports resolution of both technical and compliance issues/gaps of low complexity CAPAs can be assigned and closed based on their understanding of the CAPA intent and review/approval of the associated document (i.e.PRCD ) at Management discretion/oversight.
Assists Quality Assurance Management in additional responsibilities related to the day-to-day implementation of the Quality Management Systems required to maintain cGMP compliance, and ensure the safety, efficacy and purity of the products manufactured by Biogen.
Provides training within and across functions, as applicable
Approximately 50% of time in this position will be spent on the manufacturing floor
May work on independent projects or be involved in ongoing training for junior team members
Other duties as assigned

Benefits

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 $10,000 per calendar year
Employee Resource Groups participation