Sr Associate I, Quality Control Microbiology

Biogen•Research Triangle Park, NC

23h•$81,000 - $105,000•Onsite

About The Position

We are seeking a highly motivated QC Microbiology Sr Associate I to support microbiological testing of in-process and raw materials, and environmental/utilities monitoring at RTP drug substance manufacturing facility. The Sr. Associate I is responsible for leading key operational aspects of the QC Microbiology laboratory. The Sr. Associate I performs and trains other team members on the microbial testing of all in-process drug substance, EM/UM, and raw materials samples. Additionally this role is responsible for method qualification and projects as assigned.

Requirements

Bachelor’s in Microbiology, Biology, or related field
Minimum 4 years’ experience in pharmaceutical microbiology and GMP-regulated manufacturing
LIMS experience, including using electronic notebooks
Demonstrated knowledge of microbiological assays (bioburden, endotoxin, environmental monitoring), aseptic techniques, and general laboratory techniques
Experience with document control including reviewing and editing technical documents
Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results
Able to follow procedures and complete technical tasks
Can meet cleanroom and aseptic gowning requirements
Physically able to stand long periods, bend, move carts, and lift 25 lbs
Strong written and verbal communication skills, along with proficiency in Microsoft Word and Excel
Excellent organizational skills with the ability to prioritize, follow through on tasks, and meet deadlines

Nice To Haves

Advanced knowledge of Microbiology testing and Microbiology theory
Prior experience in utilities monitoring, including gas monitoring
Prior training experience, including classroom training
Proficient in using LIMS systems, Veeva, Kneat, and Microsoft software
Knowledgeable in GMP, GLP, and GDP requirements
Advanced knowledge of all compendial test methods (Bioburden, Endotoxin, Sterility testing)
LEAN lab and Six Sigma training and/or certification
Advanced experience with microbial ID systems, ability to troubleshoot complex equipment and instrumentation (MALDI, MicroSeq)
Experience performing EM/UM excursion investigations

Responsibilities

Review test data in LIMS
Prepare quarterly EM/UM reports
Supports testing for all qualification and study directed testing
Troubleshoot complex assays
Perform microbiology testing (e.g. Bioburden, Endotoxin, plate reading, and microbial identification) following standard procedures
Conduct routine Environmental Monitoring (viable and non-viable) in controlled manufacturing areas
Collect and process utility and compressed gas samples
Comply with SOPs and controlled documents under minimal supervision
Maintain laboratory cleanliness, equipment readiness, and inventory
Perform investigations (i.e. laboratory and deviations)
Follow site safety and contamination control policies
Work overtime as required by business needs
Perform other assigned duties

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