QC Microbiology Associate
35 Leveroni Ct Novato, CA 94949 US
- Define validation program requirements and develop/implement strategies for validation programs to ensure all validations are performed and adhere to current compendial requirements.
- Develop experimental design for validation protocol execution and supplemental studies as appropriate. Coordinate and plan method validation activities, investigations and technical studies.
- Ensure quality systems are in place and followed, and execute principal investigation of deviations, LIRs, excursions, adverse trend, and child or assessment records as needed.
- Evaluate routine assay validity, calculate and summarize results, analyze data per expectations or specifications. Assist with compilation and verification of trend reports.
- Aid in the preparation of monthly and quarterly reports for in-process and environmental monitoring data, review and analysis of testing trends and Microbial Identifications.
- Coordinate troubleshooting efforts of instrumentation or reagents through hypothesis testing, laboratory notebook studies and communication with vendor technical support.
- Support tracking of contract lab tests and review of data from these labs.
- Plan and coordinate the development and publishing of investigational, comparability study, validation or method transfer protocols.
- Initiate and lead validation or special laboratory studies and track data compilation, review, verification and analysis to completion.
- Manage the creation, review and approval of technical and/or validation reports.
- Apply proactive communication upon occurrence of issues or genesis of improvement concepts. Represent department needs as part of cross-functional teams while fostering collaboration in the deciphering of paths forward and action plans.
- Readily mentor and develop staff within the method design space and/or technical aspects of QC objectives and build a scientific focused foundation for the team.
- Perform other responsibilities as deemed necessary.
- Continuously looking internally and externally for best practices and areas for improvement.
- Provides clear instruction and direction to team members to assure fast action and effective completion of technical, laboratory and/or compliance related projects.
- Leads by example with thorough, effective laboratory work and decision making that helps to motivate and inspire the team to broaden their knowledge base and elevate performance.
- Understands patient and customer needs and builds relationships as required to meet department objectives.
B.S. degree, or equivalent, in a biological or biochemical science and at least 5 years of experience in a pharmaceutical laboratory, with at least 2 years as part of a QC organization
- Detailed knowledge of quality management systems, current Good Manufacturing Practices, longstanding expertise and practice with QC principles.
- Ability to deliver all ideas and work with a compliance mindset and alignment with pharmacopeia regulations and international guidance documents.
- Demonstrated working knowledge and critical thinking with respect to certified functional activities, with subject matter expertise on several technical modules or quality management systems.
- Excellent documentation, written and verbal communication skills are essential.
- Must possess the ability to perform routine and non-routine tasks under minimal supervision while modeling initiative, self-direction, objectivity and team advocacy.
- Ability and willingness to provide input to the entire group, with proficiency in both facilitating active and open discussion and laying groundwork for logical decision making.
- Working knowledge of cGMP regulations pertaining to test result disposition, stability protocol generation and execution and critical reagent program management, is desired.
- Computer literacy is required, proficiency with Microsoft Word and Excel is essential, experience with Microsoft PowerPoint, Access, Project and/or Visio is desired.
- Expertise with laboratory software functions, such as within MODA or LIMS, is optimal.
- Fluency with experimental design and data trend / comparability evaluation per statistical models, with some advanced software experience such as with JMP or Power Pivot.
- Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements.
Candidate must be a motivated employee capable of working in a fast-paced environment to produce quality and timely results. Strong time management and organizational skills. Experience managing projects and processes. Strong people skills. Experience with meeting organization and facilitation. Practiced in technical training element and program deployment. Ability to foster a team-oriented environment. Experience authoring and reviewing SOPs, test records, work instructions, OJTs, and other controlled documents.
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