Senior Sterility Assurance Specialist

Job Description

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.Company Description

R&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.

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.