Responsible for helping to establish and maintain a multi-shift, 24/7 GMP Quality Control Microbiology function within a cGMP Quality Control environment. Responsible for assisting in the implementation and maintenance of microbiological quality control systems, programs, and activities, as well as microbiological equipment and procedures. Additionally, this position is directly responsible for working closely with Area Management to ensure the appropriate level of support and oversight is provided for production and facility activities, as well as project management activities. Responsibilities also include ensuring assays are validated to meet cGMP requirements, as well as providing QC testing services to internal clients in support of large molecule bulk drug manufacturing. Responsible for presenting microbiological programs and data to a variety of global Regulatory Agencies.
- Oversees various aspects of the Quality Control Microbiology organization, which may include the following:
o WFI, Pure Steam, Purified Water Sampling and Testing
o Compressed Air and Specialty Gases Sampling and Testing
o HVAC System Qualification, Program Development, and Testing (airborne viable/non-viable testing)
o Surface Sampling (contact plate /swab)
o Microbial Identification
o Water Chemistry Analysis
o In-Process Microbiological Control Strategy (e.g., Endotoxin and Bioburden)
o Biological Indicators
o Aseptic Gowning Program
o Disinfectant Effectiveness
- Participates in environmental Alert/Action level excursion investigations as the subject matter expert.
- Authors Environmental Monitoring, Clean Utilities, and Sanitary Utilities data trending and summarization.
- Required to work on plant floor to identify and correct microbiologically deficiencies and performs routine evaluation of aseptic practices within manufacturing.
- Assists in the development, implementation, and execution of microbiological training materials and activities for new and existing team members, as well as other functional areas.
- Potentially creates and manages Deviations, Change Controls, and Corrective and Preventive Actions related to Quality Control Microbiology.
- Works closely with Corporate Microbiology and Area Functional Management to ensure applicable Corporate and Regulatory guidelines are evaluated and implemented.
- With the support of management, designs and implements strategies to increase efficiency and productivity of microbiology operations utilizing Operational Excellence techniques.
- In cooperation with Functional Area Management and other QC Technical Specialists, assists with validation of test methods to support release of materials for production or products for commercial or clinical use. Optimizes test procedures to improve efficiency whenever possible.
- Ensure that testing is compliant with the cGMP standards established by the company and relevant regulatory agencies.
- In cooperation with Management, ensures that procedures and equipment are compliant with cGMP standards established by regulatory agencies, such as USP, EP, FDA, MCA, and ISO.
- Responsible for controlled document creation and revision (e.g., Standard Operating Procedures, Protocols, Technical Reports).
- Responsible for balancing day-to-day support for immediate functional area, as well as long term projects and investigations.
- Frequently coordinates with Area Management and/or represents Quality Control regarding discussions with stakeholders concerning results, projects, operational decisions, scheduling requirements, and investigations.
- May be responsible for indirect supervision of some laboratory staff
7+ years of pharmaceutical or biopharmaceutical industry experience, with a minimum of 6 or more years of Microbiology experience within a cGMP environment required. Candidate must have an excellent working knowledge of the principles and philosophies of microbial control strategies in a large molecule manufacturing setting.
Bachelor's degree in life Biology, Chemistry, or related scientific field is required.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation Additional Notes
Ability to communicate within and outside the organization.
Ability to independently represent the organization in providing solutions to difficult technical issues associated with specific projects and applications.
Works under limited supervision, is able to find solutions independently, can clearly present solutions for approval, and optimizes strategies for implementation.
Ability to successfully work in ambiguity.
Ability to be flexible and adaptable with changes.
Req ID 10761 Position Category Operations