Job Title: Quality Lab Associate III - Micro, 1st Shift
Design/lead experiments using sound scientific principles and develop/validate test methods for microbiological testing. Perform laboratory investigations for OOS microbiological testing results and other exceptions. Troubleshoot microbiological equipment issues. Resolve problems and implement corrective and preventive actions. Write/revise standard operating procedures, forms, protocols, test methods and change controls as needed. Work independently and fill in for supervision/management when necessary.
- Perform method development and method validation for sterility testing, sterilization validation testing, bioburden testing, bacterial endotoxins testing, and/or antimicrobial effectiveness testing of new product formulations. Design and lead experiments using sound scientific principles.
- Perform laboratory investigations for OOS microbiological testing results and other exceptions. Execute appropriate investigative testing to find or support root cause. Develop and implement appropriate corrective and preventative actions to eliminate repeat occurrences.
- Write and revise standard operating procedures, forms, protocols, test methods and changes controls.
- Perform review of test data and reports which includes overall documentation practices. Ensure compliance to company policies, procedures, cGMPs and regulatory requirements. Perform release functions in LIMS.
- Maintain a high level of expertise in current regulatory requirements and serve as plant resource for compliance to these requirements. Provide guidance to less experienced laboratory staff. Manage workflow in laboratory. Back up for Laboratory supervision and management.
- Troubleshoot and resolve instrument problems.
- Support cross-training efforts and the training of less experienced staff members.
- Participate on teams to increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
Qualifications
- Excellent organizational and project management skills and ability to handle multiple projects with minimal supervision required.
- Must have excellent writing skills and ability to present data in a logical manner.
- Good interpersonal, communication, influencing, negotiation skills.
- Understand scientific strategies and be able to invent new methods or new avenues of investigation.
- Must be recognized by all levels of the facility as a microbiology subject matter expert and be able to demonstrate leadership.
- Demonstrated effectiveness in task completion, decision making, and problem solving.
- Working knowledge of FDA regulations, application of GLPs and GMPs. Experience interacting with personnel from regulatory agencies preferred.
Education/Experience
BS in Microbiology or Biological Sciences. Pharmaceutical Microbiology experience in parenteral manufacturing required.
Must have a minimum of 5 years of experience in sterility routine and method validation testing, bioburden routine and method validation testing, bacterial endotoxins routine and method validation testing and/or antimicrobial effectiveness testing routine and method validation testing.
What We Offer
- Clean climate-controlled working environment
- Annual performance bonus potential
- 401k employer match up to 6% of your contributions
- 23 vacation/personal days
- 11 paid Company holidays
- Generous healthcare benefits
- Employee discount program
- Wellbeing rewards programs
- Safety and Quality is a top organizational priority
- Career advancement/growth opportunities
- Tuition Reimbursement
- Maternity and Parental Leave
- Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.
