Supervisor, Microbiology

PCI Pharma Services•San Diego, CA

1d•$76,000 - $85,500•Onsite

About The Position

The Supervisor coordinates all activities of the Microbiology laboratory including internal/external bioburden and endotoxin testing activities, growth promotion and biological indicators testing. The role oversees the execution of bioburden, and endotoxin method development. The position oversees the scheduling and execution of bioburden and endotoxin testing and other testing as required. The Supervisor is responsible for the management and training of the Microbiology laboratory team. The individual also writes, reviews and approves SOPs, OOSs, and deviations. This position supervises the daily execution of the contamination control program. The Supervisor is responsible for the operation the Environmental Monitoring Group, ensuring utilities and facilities are tested according to cGMP requirements. This position supervises the daily operation to support manufacturing activities and is responsible for the review and approval of routine and lot-specific Environmental Monitoring data.

Requirements

Bachelor’s Degree in Life Sciences field or equivalent experience required.
Minimum five (5) years of experience in Microbiology.
Minimum of 1 year of supervisory experience.
Ability to supervise and motivate laboratory personnel.
In-depth knowledge of microbiological methods and techniques.
Excellent verbal and written communication skills.
In-depth knowledge of Environmental Monitoring and contamination control.

Responsibilities

Ensures the lab activities are conducted in compliance with all relevant regulatory and compendial guidances.
Ensure that GLP is implemented at all times.
Acts as subject matter expert for the Microbiology laboratory including bioburden, growth promotion, biological indicators, endotoxin, and water tests.
Interacts with Project Managers to ensure all test parameters and product specifications are available.
Ensures test timelines are defined and met.
Ensures all Bioburden and Endotoxin method development and qualifications meet compendial requirements.
Interacts with clients during audits as a subject matter expert for the Microbiology laboratory.
Oversees and reviews/approves test results.
Writes SOPs, OOS and other reports as required.
Releases batch records.
Manages direct reports and schedules the tests and functions of the laboratory to meet timelines.
Ensures training of all direct reports and self is current.
Represents Environmental Monitoring, Bioburden and Endotoxin, in internal and external meetings.
Maintains laboratory performance metrics on a monthly basis.
Acts as subject matter expert for the Environmental Monitoring team.
Oversees and reviews/approves test results and SOPs.
Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture.
Directs and provides expert knowledge in the day-to-day function of the Microbiology department.
Identifies, recruits, and retains top-notch talent.
Champions PCI Pharma Services culture and empowers employees to take responsibility for their jobs and goals.
Coaches, mentors, engage and develop the team, including overseeing new employee onboarding and providing career development planning and learning opportunities.
Sets performance standards and encourages employee engagement and results through delegation, continuous feedback, goal setting, and performance management.
Maintains transparent communication.
Appropriately communicates organization information through department meetings, one-on-one meetings, and appropriate email, and regular interpersonal communication.
Provides oversight and direction to the employees in accordance with PCI Pharma Services policies and procedures.