Associate Microbiologist - 3rd Shift (401)

civica Rx•Petersburg, VA

29d

About The Position

The Associate Microbiologist 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 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.

Requirements

Bachelor's degree in a scientific discipline (microbiology degree preferred) with a minimum of 2+ years of Quality/cGMP experience in the pharmaceutical industry.
Strong project management, organization, and execution skills.
Microbiology testing and environmental monitoring experience.
Participation in activities to support regulatory agency inspections 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 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

Responsibilities

Support the establishment and maintenance of the microbiological testing laboratory to ensure compliance with cGMPs and industry standards for best practices.
Perform microbiological testing methods consistent with USP testing requirements. Including but not limited to the following microbiological testing and procedures: bioburden, bacterial endotoxin, identification of microbial isolates and objectional organisms, viable/non-viable particulate monitoring, and growth promotion studies.
Conduct and maintain qualifications of laboratory equipment as well as ongoing maintenance and calibration.
Establish and coordinate test sampling plans.
Perform microbiological testing and sample collection to support environmental monitoring (EM) and utilities systems.
Participate in verification of microbiological methods and method transfers.
Participate in the development of training programs for microbiologist.
Lead and/or participate in investigations related to laboratory operations and non-conforming results.
Identify, track, and facilitate resolution of technical issues.
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.
Promote a quality mindset and quality excellence approach to all activities.
Travel (up to 10%) may be required.