Quality Control Microbiologist

SUMMARY

The Microbiologist supports and maintains product quality by being a key contributor in conducting, and reviewing microbiologic tests, applying concepts, practices, and procedures within the microbiology/sterile field and communicating results as a Microbiology Subject Matter Expert (SME).

The Microbiologist will work with 503A operations. This is an on-site position in Ocala, FL.

ESSENTIAL FUNCTIONS AND RESPONSIBILITIES

• Performs and reviews accurate release testing according to established SOPs, including but not limited to, sterility and endotoxin, visual inspection, etc.

• Write/Review SOPs and Change Controls

• Perform Environmental Monitoring of the cleanroom areas.

• Perform testing in conjunction with laboratory investigations.

• Draft microbiological reports, including but not limited to; Environmental Action reports, Protocols, Studies, Out of Specification Reports, Summary reports, etc.

• Review and report data ensuring precise and accurate testing is performed.

• Participate in method development and validation, if requested

• Ensure that all sterile products are tested following regulatory requirements such as but not limited to: USP <795> & <797>, cGMP

• Sample result reading and data interpretation

• Maintain documentation.

• Review, trend and report environmental, personnel, in process, raw material, and finished product microbiological testing results.

• Perform and review various microbiological procedures such as media qualifications, sterilizations, growth promotion tests and identification tests

• Recognize, report and investigate any aberrant (Out of specification) test and/or sample conditions.

• Maintain historical files on organisms found in classified areas; microbial identification and trending.

• Support laboratory activities like media preparation, monitoring of incubators, refrigerators, etc.

• Actively participate in investigations as microbiology Subject Matter Expert (SME)

• Maintain and Manage the ATCC culture collection

• Prepare and send samples for microbiological identification

• Inspect, and review media fills and associated data

• Keep informed of current scientific principles and theories

• Initiate, complete and/or review OOS or Environmental Monitoring Excursion Investigations

• Provide support of general QC Microbiology Laboratory activities such as; chart reading and changing, equipment cleaning and maintenance, maintain supplies and inventory and general laboratory housekeeping

• Other duties may be assigned by management.

QUALIFICATIONS AND SKILLS

• Bachelor’s degree in Biology, Microbiology or appropriate discipline with at least 2-years experience, preferred.

• Experience with OOS investigations/deviations/Non conformances, preferred.

• Understanding of USP and Experience using aseptic techniques in GMP environment, preferred

• Experience in reports for findings from FDA and state pharmacy board inspections.

• Knowledge of different substances from small molecules to peptide, preferred.

• Willing to travel 10 – 20% to other WPN sites.

• Strong critical thinking skills

• Excellent written and verbal communication skills

• Strong leadership skills

• Ability to multi-task and ensure deliverables are completed within designated time frame

• Comfortable with public speaking

• Excellent interpersonal skills

• Any ASQ certification, preferred.

• Knowledge of pharmaceutical regulations

• Understanding of GMP requirements

• Strong microbiology laboratory and microbiological technical knowledge in a pharmaceutical environment is required.

• Knowledge of sterility methods; gamma, heat, chemical and/or filtration

• Familiarity with Rapid Microbiological Detection methods, preferred

Job Type: Full-time

Pay: $50,000.00 - $65,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Application Question(s):

• Do you have stron microbiology laboratory and microbiological technical knowledge in a pharmaceutical environment? Required
• Do you have a BS in Microbiology/Biology/Biochemistry or related sciences?
• Do you have at least 2 – 3 years’ experience with gram stains, sub-culturing and identification of microorganisms and environmental monitoring?
• Do you have experience with current practices and procedures used in microbiological and analytical laborator?
• Do you have hands-on experience with microbiological investigations ?
• Do you have good understanding of USP guidelines (<71>, <797>, <795>, <800>, <61>, <62>, <51>)?
• Do you have good understanding of FDA Good Manufacturing Practices Regulations (GMP’s), USP and OSHA safety requirements?
• Do you have communication (both written and oral), interpersonal, team building and organizational skills?

Work Location: In person