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QC New Product Development Supervisor/Associate Supervisor
Verona, WI
Job Description
Our Company:
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 a stable and growing company that offers a friendly work environment and an incredibly competitive benefits package including: 100% company paid health and dental insurance premiums for our employees and their dependents, 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 QC New Product Development (NPD) Supervisor will primarily assist the Formulations and Production Departments by scheduling the analyses of pharmaceutical samples delivered to the QC laboratory. Support will be provided by ensuring that samples are analyzed using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendial monographs; client procedures; research procedures; and miscellaneous protocols. Sample analysis will mainly support product development, materials being released for clinical trials, stability studies, and process validation. The QC NPD Supervisor is expected to understand internal procedures and reliably oversee the execution of complex analyses with little or no direction needed from management. Additionally, the QC NPD Supervisor is expected to assist QC Chemists and Scientists with analyses as needed.
The QC NPD Supervisor will have a thorough understanding of USP, ICH, and FDA guidelines as they relate to development and qualification activities and will perform laboratory investigations (i.e. quality investigations, out of specification investigations, etc.) as necessary. The QC NPD Supervisor will assist the Director of QC during client and regulatory agency audits and responses, internal CPI audits/responses, and attend meetings as directed.
The QC NPD Supervisor will perform/oversee method development and method qualification activities (i.e. method validations, compendial method verifications, method transfers, etc.). The QC NPD Supervisor is expected to have a thorough understanding and ensure the QC Analytical Chemists follow and understand all internal procedures.
The QC NPD Supervisor will be the Analytical or Supervisor Project Lead for multiple projects that are determined in coordination with the Director of QC. The position requires scheduling or performing all analyses related to each project as well as quoting, billing, purchasing, and all tasks necessary to support each project.
Essential Job Functions:
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: 100% company paid health and dental insurance premiums for our employees and their dependents, 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 QC New Product Development (NPD) Supervisor will primarily assist the Formulations and Production Departments by scheduling the analyses of pharmaceutical samples delivered to the QC laboratory. Support will be provided by ensuring that samples are analyzed using various procedures including, but not limited to, internal procedures, specifications, and analytical methods; compendial monographs; client procedures; research procedures; and miscellaneous protocols. Sample analysis will mainly support product development, materials being released for clinical trials, stability studies, and process validation. The QC NPD Supervisor is expected to understand internal procedures and reliably oversee the execution of complex analyses with little or no direction needed from management. Additionally, the QC NPD Supervisor is expected to assist QC Chemists and Scientists with analyses as needed.
The QC NPD Supervisor will have a thorough understanding of USP, ICH, and FDA guidelines as they relate to development and qualification activities and will perform laboratory investigations (i.e. quality investigations, out of specification investigations, etc.) as necessary. The QC NPD Supervisor will assist the Director of QC during client and regulatory agency audits and responses, internal CPI audits/responses, and attend meetings as directed.
The QC NPD Supervisor will perform/oversee method development and method qualification activities (i.e. method validations, compendial method verifications, method transfers, etc.). The QC NPD Supervisor is expected to have a thorough understanding and ensure the QC Analytical Chemists follow and understand all internal procedures.
The QC NPD Supervisor will be the Analytical or Supervisor Project Lead for multiple projects that are determined in coordination with the Director of QC. The position requires scheduling or performing all analyses related to each project as well as quoting, billing, purchasing, and all tasks necessary to support each project.
Essential Job Functions:
- Mentors, trains, and assists in the supervision of the New Product Development team.
- Assists the Director of QC in the prioritization of the workload and providing updates in the form of notifications and reports internally and externally.
- Serves as a technical resource for the team including troubleshooting equipment and document review.
- Interacts with clients, vendors, and/or contract laboratories from the development phases through clinical trial (i.e. GMP phase).
- Composes, reviews, and approves: SOPs, R&D/analytical methods, material specifications, deviations, and/or out-of-specification investigations.
- Formulates, examines, and implements protocols and summary reports related to stability studies, method validations, method transfers, and/or method verifications.
- Performs and oversees testing involving dissolution, HPLC, GC, UV analysis, and various wet chemistry procedures.
- Develops and validates methods and material specifications based on compendial or client transferred methods.
- Maintains awareness of changing regulatory and industry requirements (i.e. USP, FCC, EU, JP, etc.).
- Performs final review of laboratory notebooks and equipment calibrations.
- Participates in laboratory cleaning activities and maintenance.
- 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.
- Bachelor's degree in chemistry or related field.
- 3 years of supervisory experience in a cGMP pharmaceutical environment preferred. Advanced degree may be substituted for experience.
- An understanding of USP, ICH, and FDA guidelines as they relate to development and qualification activities.
- Thorough knowledge and understanding in the use, methodology, and troubleshooting of QC analytical equipment (i.e. HPLC, GC, and/or dissolution apparatus) and method development.
- Proven demonstration of supervisory and 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.
Job Summary
Start Date
As Soon As Possible
Employment Term and Type
Regular, Full Time
Hours per Week
40
Work Hours (i.e. shift)
8AM - 5PM
Salary and Benefits
Based On Experience
Required Education
Bachelor's Degree
Required Experience
3+ years
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