Associate Microbiologist

SPECIFIC DUTIES, ACTIVITIES AND RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

• Under the supervision of other scientists, works on problems of limited scope where analysis of data requires evaluation of identifiable factors. Demonstrates potential for technical proficiency and scientific creativity.
• Under the supervision of other scientists, carry out activities in support of the manufacturing of pharmaceutical products. These activities include compendia! microbial testing of raw materials, in process materials, and finished products within scheduled timelines.
• Perform environmental sampling and testing.
• Perform USP water sampling and testing.
• Perform identification of microorganisms.
• Maintain notebooks within GMP standards and SOPs. Accurately report results, and provide detailed records of results and conclusions.
• Provides written and verbal updates on projects and activities as required.
• Is familiar with Quality Systems such as: Compliance Wire, Trackwise , Documentum.
• Assist other scientists, as necessary, for timely project completion and support other lab personnel as required.
• Comply with Health, Safety and Environmental responsibilities for the position.
• Other tasks as assigned.

POSITION REQUIREMENTS:

Education: MS/BS Chemistry/Pharmacy or AA with equivalent experience

Experience: 0 (MS) -5 years applicable industry experience preferably in pharmaceutical microbiology

Knowledge/Skills: Working knowledge and application of scientific principles and aseptic techniques . General knowledge of compendia! microbiology requirements. Experience with computer software associated with word processing and spreadsheets

Job Qualifications

Bachelor's degree with 7-9 years related experience, Master's degree with 6 years related experience, or Doctorate degree with 2 years related experience

• Either E&L (Extractables & Leachables) experience or full-time review experience

• Proficient in Microsoft Office (Word, Excel, and PowerPoint)

• Ability to work in a fast-paced pharmaceutical environment

• Excellent verbal and written communication skills

• Excellent attention to detail

• Ability to read, analyze, and interpret complex documents.

• Ability to read, comprehend, and communicate instructions and written procedures.

• Ability to review and revise documents with proficient grammar and spelling skills.

*Technical preferences for the role

• Experience with HPLC, GC-FID, GC-MS, LC-MS, Characterizations and/or other Extractables & Leachables techniques.

• Working knowledge of ChemStation, Empower or other similar software.

• Demonstrate technical proficiency in analytical methodology and adherence to cGMP regulations.

• Experience working in a cGMP environment.

• Prior CRO experience is a plus

Supervises: None

• Physical/ Mental Requirements: Mathematical and reasoning ability
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds. Be accessible to laboratory and pilot plant area(s) and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

Work Environment: Individual's primary workstation is located in the laboratory area, where the noise level is low. Employee may be present on the manufacturing floor where the noise level is low to moderate.