Microbiology Analyst I

Job Summary

Performs GMP testing of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology.

Area Of Responsibility

• Record GMP data, monitor and evaluate QC systems and equipment

• Recommend improvements to procedures, and revise SOPs and GMP documentation as required

• Interact with internal and external auditors including government agencies and contract manufacturing representatives

• Perform release, stability, validation and complaint follow-up assays on raw materials, in-process and final products

• Perform microbial identification related to product and environmental testing

• Perform sampling of raw materials as required for QC testing

• Perform routine quality control testing as required and monitors or evaluate systems, equipment (i.e. water systems, environmental chambers, sample collection and testing instruments/equipment)

• Maintain records in paper based or computer based systems

• Execute method validation protocols related to product testing

• Author summary reports for executed method validations

• Author deviation reports and microbiological assessment reports related to departmental activities and product support

• Provide technical input on product testing issues and instrumentation/equipment

• Serve as liaison to service, calibration and technical representatives

• Conduct and document assay failure and complaint investigations

• Ensure that laboratory is in cGMP compliance and conduct inspections

• Other duties as assigned

Work Conditions:

• Lab

• Office

• Laminar flow and biosafety hoods

• Exposure to noise, bio-hazardous (live cultures), and chemicals

• May entail exposure to radiation within NRC limits

• Exposure to or use of syringes and needles

• Exposure to non-hazardous and hazardous chemicals and materials

• Exposure to biological safety cabinets

• Requires work in class 100K, 10K or 100 clean room (mask and boots in conformance with environmental dress codes

• Moderate noise, oven heat, open flame, chemical fume hoods areas requiring wearing appropriate safety equipment (i.e. gloves, lab coat, safety glasses and respirator)

Physical Requirements:

• Stand, sit, walk, use hands and fingers to handle or feel, reach with arms and hands, talk or hear, stoop, kneel, crouch or crawl.

• Close vision; depth perception; ability to adjust focus

• Use of repetitive motion

• Able to operate computer/office machines

• Lift up to 25 lbs.

Travel Estimate

Up to 0%

Education and Job Qualification

• BS in Microbiology or relevant experience required

Experience

• 0-2 years related experience in a Pharmaceutical/drug (FDA Regulated) industry preferred

• Experience in pharmaceutical microbiology and microbiology testing not limited to endotoxin, method validation, sterility, bioburden, microbial identification, growth promotion and environmental monitoring testing; ability to perform standard and non-standard microbiology techniques to analyze product

• Excellent verbal, written and interpersonal communication skills

• Proficient at following specific instruction (i.e. written SOPs)

• Working knowledge of cGMP/GLP

• Good computer skills including word processing and working with spreadsheets

The presently-anticipated base compensation pay range for this position is $74,500 to $82,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.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.

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.