Sr Associate II, Quality Control Investigator

Biogen•Durham, NC

5d•$91,000 - $118,000•Onsite

About The Position

The Sr Associate II will support and lead team initiatives regarding compliance, documentation, writing deviations, lab exceptions, actions, and environmental excursions. The Sr Associate II must have practical knowledge of current regulations and cGMPs to ensure all work is performed in a cGMP manner, with adherence to regulatory regulations. What You'll Do Investigate discrepancies and capture activities in writing. Ensure appropriate corrective actions are captured, as applicable, for laboratory deviations and exceptions Author technically sound moderately complex reports with minimal guidance Support laboratory operations, to include QU, and actively and effectively communicate across functional groups and levels for completion of deliverables Initiate and monitor QC laboratory documentation, such as Standard Operating Procedures and periodic review of laboratory procedures and see them through to completion May provide Quality Unit (QU) approval for minor deviations, lab logbooks, and Analytical Instrument Validation (AIV) reports Participates in process improvements, supports management and QC teams Other duties as assigned Who You Are You are passionate about solving technical, compliance gaps and areas for improvement or remediation related to quality or process. You are confident in making decisions that have potential compliance impact to methods, results, products, and/or quality systems. You work effectively, independently and within a team framework across business and multiple levels.

Requirements

Bachelor's degree, preferably in a field of science or biotechnology
A minimum of 5 years' relevant experience in quality oversight of a biotechnology or pharmaceutical manufacturing operation
Thorough understanding and demonstrated expertise in conducting investigations in a biotech or pharma GMP environment within Quality Control labs
Good working knowledge of operations/quality systems understands work processes of QC operations/support teams (e.g., strong test method/scientific base)
Excellent technical writing skills; authors technically sound, simple to moderately complex reports and complex reports with limited guidance

Nice To Haves

Proficient in Trackwise, LabWare, LIMs, Kneat, and Veeva

Responsibilities

Investigate discrepancies and capture activities in writing.
Ensure appropriate corrective actions are captured, as applicable, for laboratory deviations and exceptions
Author technically sound moderately complex reports with minimal guidance
Support laboratory operations, to include QU, and actively and effectively communicate across functional groups and levels for completion of deliverables
Initiate and monitor QC laboratory documentation, such as Standard Operating Procedures and periodic review of laboratory procedures and see them through to completion
May provide Quality Unit (QU) approval for minor deviations, lab logbooks, and Analytical Instrument Validation (AIV) reports
Participates in process improvements, supports management and QC teams
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