Microbiologist II - 2nd Shift

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.

Position Responsibilities

* 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.

Minimum Requirements

Education required/ preferred:

* BS or BA in an appropriate scientific discipline (e.g. biology, microbiology, biology)
* 1-3 years pharmaceutical microbiology experience

Preferred Skills/Qualifications:

* 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.

Skills/Competencies:

* Knowledge of laboratory safety, material safety; working knowledge of cGMPs, GLPs, and FDA requirements.
* Self-motivated, energetic, enthusiastic, and team oriented.

Other Skills:

* 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.