Senior Sterility Assurance Specialist
4 weeks ago
Essential Functions and Responsibilities
- Championing sterility assurance principals at the site in the areas of aseptic processing, and contamination control.
- Support the site compliance to the global microbial control standards/procedures on environmental monitoring, critical utilities, contamination control strategy, clean-room management, microbiological methods and validations, sterilization and aseptic processing controls, disinfectant efficacy studies and microbial risk assessments.
- Assist with the design of the contamination control strategy.
- Develop and maintain the microbial contamination/Cross contamination risk assessment (HACCP).
- Develop and maintain the EMPQ strategy and provides oversight of the EM testing program for regulatory compliance and technical soundness.
- Participate in new product introduction teams as the sterility assurance SME to ensure new products/processes are designed with proper microbial controls.
- Act as compliance and innovation subject matter expert during the selection and qualification of laboratory equipment for microbiological testing including Rapid Microbial Methods (RMMs).
- Assist with relevant internal and external inspection responses/action items related to contamination control issues.
- Establishes and implements appropriate training programs in collaboration with training leads.
- Ensure alignment and harmonization regarding global microbiological/aseptic standards, policies, practices, procedures and compendial/regulatory requirements across sites.
- Plays a critical role in facility design and modification, cleaning and sanitization program, operator qualification, gowning certification, manufacturing support, training, investigations, inspections, and audits.
- Troubleshoots contamination related issues occurring in internal and external manufacturing sites.
- Support site QC in microbiology deviations, LIR, OOS, Change controls and CAPA records.
- Owns change control tasks associated with qualification or program revisions.
- Regular communication to senior levels of management for issues related to contamination control.
- Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, etc.
Required Education, Skills, and Knowledge
- Bachelor’s degree in a relevant discipline (biological sciences or equivalent).
- Minimum Six (6+) years of experience in the pharmaceutical industry within a Quality Control microbiology role.
- Demonstrate knowledge of cGMP/ICH/FDA/EU compliance regulations and USP, EP and JP monographs for microbiology. Knowledge and familiarity with Annex 1.
- Strong knowledge of microbiological and sterility testing, media fills, environmental monitoring, clean room qualification and management, quality control endotoxin, mycoplasma testing, and microbiological control strategy required.
- Broad knowledge of quality control for biologics with experience in microbial contamination control.
- Experience with microbiological risk assessments.
The cornerstone of our success: a knowledgeable and experienced recruiting team.
Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.Company DescriptionR&D Partners is a national staffing firm focused in the areas of: Scientific, Clinical Research and Engineering. Our team offers well over 200 years of combined staffing experience providing consulting, direct hire & outsourcing solutions with our west coast offices in San Francisco, Redwood City and San Diego, CA and our east coast offices located in Harrisburg, PA and Tampa, FL.\r
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The cornerstone of our success: a knowledgeable and experienced recruiting team.\r
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Our life sciences recruiters, clinical research recruiters and engineering recruiters are uniquely specialized. After a detailed assessment of our clients’ needs, we can then identify appropriate candidates utilizing our established network of professionals. R&D Partners takes a proactive approach to recruiting, establishing relationships with experienced passive candidates so when the time is right, we can combine our candidates’ talents with our clients’ opportunities.
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