civica Rx - Petersburg, VA
posted 4 days ago
About the position
The Supervisor Microbiology 3rd Shift will join the Civica, Inc. ('Civica') organization and its newly created team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica's new fill-finish facility dedicated to the manufacture and supply of essential generic sterile injectable medications. The responsibilities of the position include supporting facility qualification and equipment validation. The Supervisor will oversee the Microbiology and QC Chemistry teams. The role is essential to ensure the Petersburg site's microbiology laboratory and testing comply with applicable regulatory standards (e.g., Current Good Manufacturing Practices and FDA Guidance documents) and expectations for the development and reliable supply of quality medicines. Responsibilities also include but are not limited to, the generation and/or review of procedures, reports, and other records necessary to support the implementation and maintenance of a microbiology laboratory that meets or exceeds FDA and EU Annex 1 requirements.
Responsibilities
- Responsible for performance management and coaching of direct reports.
- Foster compliance with cGMPs and industry standards for best practices.
- Provide technical expertise and microbiology representation in cross-functional projects and process assessments.
- Review microbiological testing methods consistent with USP testing requirements.
- Coordinate qualifications of laboratory equipment as well as ongoing maintenance and calibration.
- Establish and coordinate test sampling plans. Approve results in Veeva LIMS.
- Manage microbiological testing and sample collection to support environmental monitoring (EM) and utility systems.
- Manage ordering and release of laboratory inventory.
- Review/approve verification of microbiological methods and method transfers.
- Participate in the development of training programs for microbiologists and manufacturing aseptic techniques and gowning.
- Lead and/or approve investigations related to laboratory operations and non-conforming results.
- Perform impact assessments and change controls.
- Troubleshoot technical issues with laboratory instruments.
- Proactively identify and work collaboratively to resolve problems, taking risk-based and compliant approaches to solutions.
- Author and/or review SOPs, protocols, reports, test methods, and product specification documents as applicable.
- Create and/or revise Risk Assessments.
- Promote a quality mindset and quality excellence approach to all activities.
- Travel (up to 10%) may be required.
Requirements
- Bachelor's degree in a scientific discipline (microbiology degree preferred) with a minimum of 8+ years of Quality/cGMP experience in the pharmaceutical industry, including at least 2 years managing personnel.
- Strong project management, organization, and execution skills.
- Microbiology testing and environmental monitoring experience.
- Participation in activities to support regulatory agency inspections is required.
- Excellent interpersonal and written communication skills and experience using various software/electronic applications required.
- Self-motivated, flexible, and able to work in a small, fast-paced, dynamic environment.
- Ability to work autonomously and within established guidelines, procedures, and practices.
- Committed to delivering high-quality results, working with others to overcome challenges, and focusing on what matters.
- Continuously looking for opportunities to learn, build skills, and share knowledge with others.
Nice-to-haves
- Experience in sterile injectable manufacturing, aseptic processing, and facility qualification.
- Environmental monitoring in isolators and cleanrooms per Annex 1 requirements.
- Experience with the following microbiological testing and procedures.
- Sterility testing and method suitability testing per USP <71>.
- Acceptance testing and use of biological indicators.
- Depyrogenation validation.
