Brooksville, FL US
Senior QC Microbiologist
Title: Senior QC Microbiologist
Location: Brooksville, FL
Schedule: Mon-Fri 8am-5pm
Salary: $65k and up based on experience
Employment Type: Direct Hire
Our client is a US-based sterile injectable manufacturer of parenteral drugs with a world-class facility focused on ready-to-use pre-filled syringes and vials. The company's product line includes small molecule 505(b)(2) NDA and 505(j) ANDA syringe and vial products, and it serves as an outsourced contract manufacturing partner for strategic pharmaceutical companies.
The microbiology department is responsible for microbiological cGMP testing of sterile and non-sterile products developed and manufactured by our client. This includes routine microbiological testing of products for release and stability (i.e. microbial enumeration, endotoxin, sterility, antimicrobial effectiveness, and microbial identification), development and validation of microbiological methods, monitoring and maintaining the laboratory in good quality, assisting in the validation and periodic certification of the manufacturing facility, developing and executing equipment protocols, and performing work in a safe, accurate and professional manner.
The Sr. QC Microbiologist works with the microbiology Director and/or Supervisor to review processes and procedures, assist in testing as needed, and perform projects in the Microbiology department, as well as works closely with manufacturing and Quality Assurance for harmonization between departments.
The employee should successfully meet schedules in a high quality and professional manner and ensure work areas conform to cGMP regulations, Standard Operating Procedures and Corporate Policies.
Specifically, while working independently, this person will perform the following duties adhering to written Standard Operating Procedures (SOPs), USP/NF, or written work instructions:
- Responsible for coordinating, executing, and implementing the results of projects that improve procedures, process, systems, and technique.
- Review of microbiology systems to identify areas where improvement or revision may improve accuracy, efficiency, and compliance.
- Responsible for microbiology quality control testing of raw materials, in-process, finished product and stability samples.
- Perform investigations, deviations, and troubleshooting in a technical role.
- Performing microbiology development and validation activities, such as but not limited to bacteriostasis and fungi stasis, neutralization efficacy, LAL validation, and microbial enumeration validation.
- Perform microbiology support activities of the sterile manufacturing areas, such as environmental monitoring.
- Develop test protocols, review and write technical reports, write SOP s, and review stability data.
- Work closely with QA and QC Chemistry to implement procedures in compliance with regulatory requirements.
- Perform review of laboratory notebooks for accuracy and compliance to the analytical method.
- Write and perform review of QC microbiology reports.
- Set annual goals with supervisor to improve job and individual skills and abilities; Maintain a high level of quality of product and improved established efficiency and yield standards
- All other duties as assigned by management
Bachelor s Degree in Biology, Microbiology, Chemistry, Biochemistry, Engineering or equivalent with 5 years of experience in sterile pharmaceutical and/or biotechnology manufacturing. OR equivalent combination of relevant education, experience and training
- Knowledge of microbiological laboratory techniques
- Knowledge of aseptic technique
- Experience working in QC laboratory
- Ability to learn new laboratory equipment and techniques
- Excellent verbal and written communication skills
- Knowledge of cGMPs, USP/EU regulations, and ICH guidelines
- Analytical reasoning, root cause analysis and problem solving
- Technical writing: write, read, understand, and interpret technical writing and instructions
- MS Office skills; particularly Word and Excel
- Math and calculation skills
- Multitask and coordinate with operations and quality assurance simultaneously
- Work with a wide range of people to solve problems and resolve issues
- Work in a fast-paced environment
- Ability to maintain flexible task schedule and workflow
- Highly detail oriented with good record keeping skills
- Positive personality with integrity and a commitment to our client's mission
- Excellent people skills, with experience collaborating in a multi-disciplinary, diverse, and dynamic team
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.