Analyst, Quality Control Microbiology

This position will be four (4), Ten (10) hour days, Sunday to Wednesday or Wednesday to Saturday on day shift.

Responsibilities:

• Executes routine and non-routine analysis, may include, but not limited, to cGMP release and characterization testing using microbial techniques such as environmental and utilities monitoring in clean rooms, bioburden, endotoxin, growth promotion, sterility, and cell culture assays.
• Conducts routine product and raw material testing, environmental monitoring of the manufacturing cleanrooms and processes, participate in method and instrument qualifications, and support investigative testing. 
• Document laboratory test results in GLIMS, worksheets, forms, and logbooks utilizing Good Documentation Practices in a timely manner.
• Assists in drafting and revising SOPs and reports.
• Manages the use and maintenance of scientific equipment and instrumentation, computer systems.
• Responsible for limited range of laboratory support functions and procedures as assigned, developing capability in basic technical skills, disciplines, and procedures within assigned discipline area(s).
• May be assigned to specific disciplines, but will support all necessary laboratory and assay functions, including housekeeping, safety, logbook/equipment use and maintenance, and updates to existing operating procedures.
• Capable of delivering to assigned work schedule with attention to detail and accuracy.
• Adheres to proper cGMP’s including good housekeeping, proper protection of product quality and integrity, and personal hygiene.
• Notifies management and initiates events (such as Laboratory Investigations) in the quality systems, with guidance from senior analysts or management.
• Assist in special projects on analytical and instrument problem solving by execution of assay.
• Gain familiarity with basic process improvement methodologies, learning and applying concepts of lean lab and six sigma that are applicable to the QC lab environment.
• Other related job duties as assigned.

Requirements:

• Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field.
• Ability to gown for entry into Aseptic core and supporting areas and lift approximately 25 pounds.
• Learns to use professional concepts, Builds Relationships & Demonstrates Teamwork.
• Adheres to expected levels of conduct, including attendance and appropriate, professional behavior.
• Applies company policies and procedures to resolve routine issues.
• Ability to communicate and work in a team environment.
• Normally receives detailed instructions on all work.

The pay range for this position at commencement of employment is expected to be between $57,800 and $107,300/year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.