QC Analyst III, Microbiology

Overview

GENERAL SUMMARY OF POSITION:

The QC Analyst III Microbiology Supervisor is responsible for supervising routine, non-routine and in process EM and water collection and testing activities. Responsible for the implementation of methods and procedures for testing and evaluating product, water and environmental quality.

Responsibilities

ESSENTIAL FUNCTIONS:

• Supervises the daily operations of the Quality Control Microbiology group by supervising the sampling and testing of routine and in process EM, water and product samples. Ensures sample collection and testing are executed as scheduled. Reviews completed assays for accuracy. Communicates with manufacturing management regarding test results.
• Maintains compliant LIMS EM and water module including specification changes and creation of new sites in a timely manner. Interfaces with IT to test out and promote changes from the test instance through validation instance.
• Assures that in-process, bulk, and final container Microbiology testing is completed on schedule.
• Reviews and analyzes data generated in QC Microbiology.
• Provide technical support for laboratory staff. Troubleshoots assays as necessary.
• Maintains compliance of QC Microbiology laboratory. Monitors the maintenance of lab supplies and reagents and proper disposal of hazardous materials.
• Responsible for training and supervising analysts performing assays according to SOPs. Provides documented retraining of Laboratory staff as necessary. Plans and assigns duties according to the nature of the job to be accomplished and the skills of personnel. Ability to motivate personnel to work effectively.
• Develops relevant SOPs and revises existing SOPs as required. Reviews SOPs and in-process forms to meet FDA-mandated annual reviews.
• Investigates Laboratory incidents/deviations and write incident/deviation reports, out-of-specifications reports and other technical reports as needed.
• May assist in the development or validation of new assay procedures or equipment in the Quality Control department.
• Clearly explain laboratory procedures to regulatory authorities as required.
• Prepares written/oral reports for presentations to Management or Laboratory Staff
• Perform other additional job-related duties as required

Qualifications

REQUIRED QUALIFICATIONS:

• Requires a Bachelors Degree in Biology or related field with a minimum 5 years of relevant experience or equivalent
• Ability to recognize deviations, and recommend corrective action
• Prior experience in a cGxP regulated environment.
• Demonstrated ability to train and supervise others
• Ability to conduct complex troubleshooting
• Computer literate and proficient in MS Word, Excel and other relevant electronic systems
• Excellent problem solving, critical thinking, time management and organizational skills. Demonstrated ability to multitask and consistently meet deadlines
• Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills.
• Excellent written and verbal communication skills. Ability to communicate effectively (up, down, and laterally) with others
• Demonstrated initiative through past experience
• Ability to work effectively both independently and as a member of a team

• Prior experience with LIMS is preferred
• Requires ability to work flexible, and, at times, extended work hours to meet business needs