Microbiologist II

Job Summary

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

• Record GMP data, monitors and evaluates QC systems and equipment
• Implement improvements to procedures, and revises SOPs and GMP documentation as required
• Interact with internal and external auditors including government agencies and contract manufacturing representatives
• Perform sterility and endotoxin testing for release, stability, and validation for raw materials, in-process and final products
• Maintain Sterility and Endotoxin testing areas in a state of cGMP compliance
• Perform and review growth promotion testing data for qualification of microbial culture media
• 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 evaluates systems, equipment (i.e. water systems, environmental chambers, sample collection and testing instruments/equipment)
• Maintain records in paper based or computer based systems
• Author and execute method validation/suitability protocols related to product testing
• Author summary reports for executed method validation/suitability protocols
• Author deviation reports and microbiological assessment reports related to departmental activities and product testing
• Review Microbiology testing data as required
• Coordinate receipt of raw material, in-process and final product samples for testing
• Maintain metrics for receipt and processing of samples for microbiology testing
• 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
• Perform other duties as assigned

• 2-4 years related experience in a Pharmaceutical/drug (FDA Regulated) industry preferred
• BS in Microbiology or related field or equivalent industry experience is required
• 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

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, and may be eligible for the Long Term Incentive 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.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

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, affectionate or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.