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.
The primary purpose of the QC Associate Scientist is to provide support to the Production and Formulations Departments by analyzing pharmaceutical and/or cleaning samples. Support will be provided by analyzing samples using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendial monographs, client procedures, research procedures, and miscellaneous protocols. The Associate Scientist is expected to understand internal procedures and reliably conduct analyses with limited supervision. In addition, support is provided by ensuring the essential job functions of this position are completed as part of the daily and/or weekly schedule.
Essential Job Functions:
Ensures adherence to CPI Standard Operating Procedures, analytical methods, protocols, company standards, and applicable regulations.
Analyzes pharmaceutical or cleaning samples
Leads analytical method feasibility, validations, transfers, and verifications
Advanced understanding and use of Empower software
Proficient in creating/editing new or existing internal procedures and specifications without assistance
Trained on at least two of the following: HPLC, GC, dissolution, or applicable advanced instruments
Ability to be Trainer on at least one of the following: HPLC/GC/Disso
Ability to draft validation/verification protocols with guidance from QC Leadership or other trained individuals.
Analytical Lead on 2 or more projects with some guidance from QC Leadership
Assists less experienced staff with method training and questions
Calibrates and maintains QC analytical equipment
Communicates with Production, Formulations, and QA departments as required
Maintains a cGMP laboratory notebook, data, forms, and/or logbook.
Performs basic and complex review in laboratory notebooks, data, or forms
Assists in maintaining a clean, organized QC laboratory.
Lifts/carries objects weighing up to 55 lbs.
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.
Thorough understanding of USP, ICH, and FDA guidelines as they relate to qualification activities.
Experience with the use and troubleshooting of analytical equipment (HPLC, GC, and/or dissolution)
Possesses good time management skills to complete assignments/projects in a timely manner with minimal supervision.
Ability to establish and maintain effective working relationships with team members, co-workers, and/or clients.
Ability to lift objects weighing up to 15 lbs. on a daily basis and up to 55 obs. Occasionally.