Coating Place, Inc. has been in the contract manufacturing industry for over 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.
Position Overview: The primary purpose of the QC Specialist is to perform review of all raw analytical data in laboratory notebooks, forms, worksheets, and logbooks. This review is to ensure that the various compounds and components were tested correctly according to compendial monographs, internal analytical methods, internal specifications, client procedures, and miscellaneous research procedures as required in internal SOPs. In addition, the QC Specialist may also assist in review of protocols, summary reports, SOPs, internal analytical methods and internal specifications to ensure the document is accurate and complete. The QC Specialist will also help create CoA’s, track QC audit observations and make sure corrective actions are completed and any other miscellaneous tasks as assigned.
Essential Job Functions:
Reviews laboratory notebooks, forms, and logbooks.
Performs review of any internal methods, specifications and protocols to ensure compliance or accuracy.
Assists with drafting protocols, summary reports and new or existing internal procedures or specifications.
Create/Ammend Certificate of Analysis
Assists with administrative support activities such as maintaining files and processing paperwork.
Coordinates/assists in change and process improvements needed.
Coordinates and tracks client and regulatory audit observations to ensure timely closure.
Maintains a cGMP laboratory notebook and forms.
Follows all CPI cGMP practices, policies, and procedures.
Follows all CPI safety practices, policies, and procedures.
Other duties as assigned.
Bachelor's degree in chemistry or related field required.
2+ years of experience at Coating Place, Inc. or in a cGMP pharmaceutical environment. An advanced degree may be substituted in place of experience.
Must be detail oriented and possess strong written, organizational, and communication skills.
Advanced time management skills to complete review of multiple documents daily with minimal supervision.
Ability to establish and maintain effective working relationships with team members, co-workers and/or clients.
Ability to lift object weighing up to 15 lbs. on a daily basis and up to 55 lbs. occasionally.