Job Description

Job Title:  Scientist II (Microbiology)

Pay:  $35.00 - $40.00

Job Overview:  The Scientist II in Quality Control Microbiology displays an advanced knowledge in microbiological test methods, instrumentation and guides others in routine test methods.  A Scientist II participates in the mentoring and training of less experienced analysts in the group.  The QC Microbiology department contains four main functional groups. 

Job Description:

• Performs peer review of data for accuracy, completeness and conformance to specifications.
• Keeps supervisory personnel informed of all relevant events impacting the operations and performance of the department including discrepancies and out of limit conditions.
• Be able to articulate work related issues clearly and effectively to management and peers.
• Maintains knowledge of cGMPs and GLPs. Maintains knowledge of current compendial methods.
• Teach or coordinate teaching of training modules and laboratory techniques to new analysts
• Assists in authoring basic investigative studies (OOS, OOT, OOL) and other necessary documents for the Quality Control Microbiology department.
• Responsible to write/revise GMP documentation related to environmental risk assessments and associated reports, Standard Operating Procedures, Technical Protocols, Technical Reports.
• Responsible to analyze EM data, Calculating contamination recovery rates and writing EM trend reports.
• Responsible to drive quality events investigations (like Deviations), root cause analysis and writing exception documents.
• Responsible for driving of CAPA action, implementation of actions and effectiveness measurement checks.

Requirements:
• Bachelor of Science degree in a biological or other science with 4-6 years progressive laboratory experience. Equivalent combination of education and experience accepted.
• Excellent verbal and written communication skills are essential.
• Planning and organizational skills necessary for primary responsibilities.
• Must successfully execute requirements to achieve ISO 5 environment gown certification as required by supervision.