QC Microbiologist

Industry

Manufacturing and Production

Advert ID

USA/413912

Location

Aiken,Aiken

Job Type

Permanent

Hours

Full-Time

Salary Range

60000.0 - 70000.0 YEARLY

No. of Openings

1

Branch Information

Aiken, SC - (USA) 152 Rudy Mason Parkway, NE SC Aiken , SC - 29801 Phone : 803-642-0750

ContactNumber

803-642-0750

Job Description

• Oversee and conduct USP and EP microbiological analyses of raw materials, finished products, and environmental monitoring samples to include:
o OOS/Atypical results investigations.
o Troubleshooting Microbiological Methods application.
o Troubleshooting laboratory instrumentation.
• Write and execute laboratory equipment qualification protocols (e.g., refrigerators, water baths, incubators, autoclaves, etc.).
• Review raw data, testing frequency, quality control specifications, and pharmacopoeia procedural revisions for correctness, compliance, and accuracy.
• Support Health Authority Audits (i.e. FDA, EMA, MRHA, CAG, etc.)

Candidates should possess knowledge and work experience in a FDA regulated customer healthcare drug facility with a clear working knowledge of GMPs. Must be self-motivated, with close attention to detail and capable of working alone or with a team. Must be willing to work any shift with a possible varying schedule to include evenings, holidays, and extended hours as business dictates. Must be able to lift 20-50 pounds. At least 20% of the position frequent movement (up and down)

Candidate should have a minimum of a Bachelor Degree in Biology but a Bachelor of Science Degree in Microbiology is preferred. Minimum of 7 years’ experience in cGMP Laboratory environment, preferably as SME role. Working knowledge of particle counters, air sampling equipment, laboratory bio-safety, Quality Management standards, and GMP requirements. Must be drug free and have a 7 year clean background.