Performs biological assays of clinical and/or commercial product raw materials, production in-process samples, finished product, environmental monitoring samples, process & cleaning validation samples and components as well as some specialized techniques. Assays are qualitative, quantitative, and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements, Mallinckrodt standard operating procedures, and approved license requirements. Results are compared with specifications and documented. Incumbent has mastered most or all of fundamental technical and quality concepts. May provide guidance and training to more junior staff members. This position is on a 4x10 schedule, 11 AM - 10 PM.Position Responsibilities
Minimum RequirementsEducation required/ preferred:
- Performs biological assays of clinical and/or commercial product raw materials, production intermediate and bulk samples, finished product, environmental monitoring samples, process & cleaning validation samples, package samples and components. Laboratory assays included Particulate testing, growth promotion of media, sterility testing, raw material testing, bioburden, membrane filtration, plate reading, endotoxin testing and environmental monitoring. Works in a team environment to support internal and external customer microbiology testing services. Takes initiative; seeks out additional assignments, etc.
- Identifies basic technical issues, atypical or out-of-specifications test results, instrument malfunctions and methodology problems and leads the investigation process to resolve and correct.
- Accountable for the accuracy and validity of testing results. Performs mathematical calculations, interprets results, records observations. Ability to keep accurate records and performs monthly trend analysis for microbiology data to identify potential concerns with product quality and correct deviant situations. May utilize Laboratory Information Management Systems. Develops problem solving skills.
- Maintains all related records, prepares and records media, buffers and reagents, etc., and maintains work area in a neat and orderly manner. May assist in coordinating the testing activities of the group. Ability to represent the microbiology department on relevant teams (Kaizen, Lean Sigma) to help improve processes throughout the facility. Assist in maintaining inventory and reconciliation of laboratory supplies and assist in protocol execution when needed.
- Learns to analyze and interpret project/study/investigation results and findings. Determines next steps under guidance of manger and in compliance with applicable regulations; carries out technical and administrative duties as assigned.
- BS or BA in an appropriate scientific discipline (e.g. biology, microbiology, biology)
- 1-3 years pharmaceutical microbiology experience
- Good interpersonal and verbal/written communication skills; able to use computer for data analysis.
- Ability to perform multiple tasks simultaneously with accuracy and precision.
- Ability to follow directions; read and understand SOPs.
- Knowledge of laboratory safety, material safety; working knowledge of cGMPs, GLPs, and FDA requirements.
- Self-motivated, energetic, enthusiastic, and team oriented.
- Ability to train analysts; kinetic LAL; gel-clot LAL; environmental monitoring; filtration; aseptic technique; particulate testing, investigation writing.
- ffective communication with both team members and other plant support groups.
Guerbet is a French based company with a Global reach. Our products and services are made available in more than 80 countries through our affiliates and network of distributors. We offer competitive benefits including but not limited to;
- Exempt-employee benefits start on start date, non-exempt benefits start a month after hire
- Competitive 4% 401K match + 2% profit sharing contribution
- Tuition reimbursement program for ongoing education
- 4 weeks of PTO
- Opportunity to collaborate with colleagues around the world!