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Coating Place, Inc. has been in the contract manufacturing industry for the last 40 years. Our continued goal to provide the highest quality Wurster processing has kept us at the forefront of the “fluid bed micro-encapsulation” market. Our company mission helps us to maintain this focus.
“Coating Place is an established pharmaceutical contract manufacturer specializing in Wurster fluid bed processing and delivery system development. We provide our customers with modified and extended release bulk active products through innovative development and manufacturing capabilities with an integrated quality philosophy.”
It is our mission to continue urging the next generation, candidates like you, into these fields and further expand the capabilities of the industry through their capabilities.Coating Place is a stable and growing company that offers a friendly work environment and an incredibly competitive benefits package including: health, dental, and vision insurance, a generous paid time off program to help balance work and personal life, and pre-tax 401(k) and after-tax Roth 401(k) contribution options with the company matching up to 5% of gross wages that is 100% vested at the time it is added to the employee’s account. In addition, Coating Place may choose to make a profit sharing contribution to your account!
POSITION OVERVIEW:
The primary purpose of the QC Environmental Monitoring (EM) Associate Supervisor is to oversee and train the QC Environmental Monitoring group. In particular, this position is responsible for the entire environmental monitoring program which includes sampling, investigating, and trending of the purified water system, compressed air system, and production/ancillary facility (viable and non-viable air, surface and ATP). The QC EM Associate Supervisor leads the development of new and/or revises existing environmental monitoring procedures, protocols (i.e. method validations, transfers, and verifications), and implementation of new equipment.
The QC EM Associate Supervisor in conjuction with the QC Manager is responsible for the entire cleaning verification/validation program. The QC EM Associate Supervisor will oversee all testing activities associated with the system which will require collaboration with various departments as well as directing of individuals in the EM team as needed to complete the required tasks as outlined in the applicable SOPs. The QC EM Associate Supervisor adheres to and ensures staff members follow QC laboratory SOPs and analytical methods to support compliance with company standards and applicable regulations.
ESSENTIAL JOB FUNCTIONS:
§ Performs and trains staff on sampling per environmental monitoring and cleaning validation/verification program requirements.
§ Supervises QC Utility Operator and EM team.
§ Ensures adherence to environmental monitoring and cleaning program SOPs, analytical methods, company standards, and applicable regulations.
§ Assists in the development of new environmental monitoring procedures, protocols (i.e. method validations, transfers, and verifications) and implementation of new equipment.
§ Communicates with CPI management and clients about environmental monitoring data, notifications, investigations, summary/trending reports, quoting, and purchasing needs.
§ Calibrates and maintains microbiological equipment.
§ Maintains awareness of applicable changing regulatory and industry requirements (i.e. USP, EU, JP, etc.).
§ Maintains a cGMP laboratory notebook, data, forms, and/or logbook.
§ Reviews laboratory notebooks, data, forms, and/or logbooks of other lab personnel.
§ Assists in maintaining a clean, organized QC laboratory.
§ Conducts annual performance reviews and meetings.
§ Follows all CPI cGMP practices, policies, and procedures.
§ Follows all CPI safety practices, policies, and procedures.
§ Other duties as assigned.
EDUCATION/SKILLS/KNOWLEDGE REQUIRED
§ Bachelor's degree in microbiology, chemistry or other related field.
§ 1-2 years of supervisory experience in a pharmaceutical environment or a minimum of 3 years of applicable cGMP environment experience. An advanced degree may be substituted in place of experience.
§ General knowledge and understanding in the use, methodology, and troubleshooting of analytical and/or microbiological equipment.
§ Proven demonstration of leadership skills to successfully train, direct, and motivate QC personnel required.
§ Ability to establish and maintain effective working relationships with team members, co-workers, vendors, and/or clients.
§ Ability to lift object weighing up to 15 lbs. on a daily basis and up to 55 lbs. occasionally.