QC MICROBIOLOGY LABORATORY MANAGER

Description:

Position Summary:

• Manages overall performance of the Microbiology laboratory including Quality Control testing, product development, product release, and equipment.
• Provides managerial review of testing samples in LabVantage and MODA systems, including but not limited to, finished product, in-process, stability, raw material, and water samples.
• Provides oversight and instruction for the QC Microbiology Laboratory personnel.
• Assists with additional work duties or responsibilities as evident or required.

Primary Accountabilities:

· Managerially reviews testing samples on a daily basis to ensure the Microbiology department does affect the release of product.

· Assists in procedure creation and review, and ensures staff training is complete and remains current.

· Assists in training QC and R&D analysts on identification and verification, MODA, LabVantage, and ScanRDI computer systems, and the Maldi-tof identification testing equipment; ensures QC staff training is complete and remains current.

· Oversees all testing operations of the Microbiology Department.

· Assists in the management of Quality Control laboratory personnel and helps create the Microbiology Laboratory testing schedule on a weekly basis

· Communicates effectively with management when errors in microbiology testing are discovered, and assists in training, review, and troubleshooting to resolve sample-testing errors.

· Assists in the review of documents for authorization/approval of required or necessary changes to ensure accuracy and completeness.

· Provides assistance in the purchase of required testing materials, equipment, and services, as well as scheduling the service and maintenance required by outside providers, if needed.

· Ensures timeliness in the initiation of reports, investigations for trending, OOS, and NCR’s, as needed.

· Performs routine testing, as necessary.

· Responsible for performance evaluation of laboratory personnel.

· Assists the QC Operations Manager with project management in regards to investigations, planned deviations, CAPA systems, and trending.

· Communicates Microbiology-related observations, issues, problems, discrepancies, and any violations of company policies or procedures to the QC Microbiology Operations Manager, Director of Microbiology, and/or Quality management, or designee.

· All other duties as needed or required.

Requirements:

Knowledge, Skills & Abilities:

· B.S. Biology, Microbiology or Life Science Degree.

· 2-5 years of pharmaceutical microbiology experience, preferred.

· 2 – 3 years of supervisory experience and the ability to supervise, train, and discipline employees.

· 2 – 5 years of experience with Microsoft Office applications.

· Experience with USP and FDA Guidance, cGMP, Aseptic Processing, Environmental Monitoring Techniques. Experience with various QC Microbiology test methods including, but not limited to bioburden, identification, bacterial endotoxin, sterility, and particulate matter.

· Highly organized, with great written and oral communication skills.

· Specific expertise, skills, and knowledge within Microbiology gained through education and experience.

· Should possess a good understanding of quality assurance and quality control, stability programs, and product development.

· The ability to manage oneself effectively, demonstrate integrity, be productive under pressure, and achieve developmental goals.

· Possess a strong attention to detail.

· An ability to manage a multitude of resources and to be accurate and current with data and information.

· The ability and willingness to change direction and focus to meet shifting organizational and business demands.

· The ability to take strategic objectives and accept accountability, motivate and influence others, think globally, and leverage diversity.

· The ability to set clear targets and use performance measures to assess risk and manage opportunities effectively.

· A broad perspective that aligns decisions to organizational objectives and long-term consequences of day-to-day activities.

· Position requires lifting (up to 40lbs), vision (20/20), standing (20%), sitting (50%), walking (30%), talking, typing, and hearing.

· Incumbents are required to wear specified protective equipment as necessary.

· Hours of work: Monday through Friday, on an 8-hour shift. Additional work may be required during weekends and after business hours depending on company demand.

· Salary range: based on experience