UPM is a service organization and our employees are our greatest asset. This is why we seek highly skilled and highly motivated individuals to become a part of our team. We look for people that share a passion for the pharmaceutical industry as well as for hard work, creativity, and growth. Our employees are devoted to our mission of rapidly advancing pharmaceutical technologies and products on behalf of our clients. At the same time, we work in an enriching environment, work as a team where initiative and performance is rewarded. If you share our commitment to teamwork, enjoy a challenge, and want to feel good about the work you do, please contact UPM at firstname.lastname@example.org to discuss our current open positions.
UPM offers competitive salaries and an excellent benefit package.
Current Open Positions at UPM Pharmaceuticals
Manufacturing Quality Assurance Specialist
Essential Duties and Responsibilities:
Assists and supports the manufacturing/packaging staff in detecting and solving compliance errors in real time during operations including:
- Evaluates deviations through notice of event reports and investigations; assigns and communicates corrective and preventative actions (CAPA) to responsible departments; provides follow-up on CAPA and assesses effectiveness of CAPA.
- Assign disposition to bulk, intermediate, finished product and components based on batch record review for compliance to the current Good Manufacturing Practices, compendia standards, and company specifications. This activity provides authorization for the transfer or use of product or components at significant evaluation points in the manufacturing process and ultimately for the release to distribution. It involves review of the batch record for the completeness and accuracy of entries, adequacy of investigation of deviations and conformance to test results with the established standards.
- Makes decisions of acceptability/rejectability of investigations from operations and the laboratory.
- Evaluate and approve in-process data in accordance with the established specifications to measure conformance of final container contents to label claim. Make decisions concerning out of limits or out of trend in-process situations.
- Determine need, schedule, prepare protocols, and evaluate attribute inspections associated with batch deviations. Evaluate attribute failures. Recommend product disposition from attribute evaluation.
- Leads or responds to quality audits when applicable to assure conformance with regulatory and internal requirements. Has the skill necessary to conduct own internal audits.
- Participates in and provides leadership for Projects as designated by upper management.
- Revises, evaluates, and approves SOPs, as necessary.
- Compile Annual Product Reviews for the commercial market, and evaluate stability data and trends; identify any preventative or corrective actions that would lead to product quality improvements and report them to upper management.
- Participate in customer complaint investigations, as necessary.
- Maintain a working knowledge of government and industry Quality standards.
Knowledge necessary to perform the job:
- Knowledge of 21 CFR 210 and 211 cGMPs and part 11 to determine disposition of product batches and raw materials.
- Knowledge of manufacturing and laboratory operations, company business plan, validation plan and financial plan.
Bachelor's degree in a technical field, i.e., Biology, Chemistry, Engineering, or Pharmacy and six to eight years of related experience and/or training; or equivalent combination of education and experience. Pharmaceutical experience preferred.
Essential Duties and Responsibilities:
The Pharmaceutical Chemist performs set up, calibration, operation, and maintenance of laboratory test equipment. Performs assigned work in a timely and safe manner conforming to regulatory, company, and compendial requirements. Adheres to cGMP, which include, but is not limited to, proper laboratory documentation and maintenance, and archiving of paperwork. Compiles reports of analytical tests, ensuring reports are accurate and complete with documentation of procedures, equipment, and reagents used in analytical testing. Develops proficient practical laboratory skills, a thorough knowledge of chemistry theories, analytical techniques, and adopts site procedures as required. Assists in the execution of protocols, method transfers, and validation studies under the guidance of more experienced analysts. May need training in the handling of controlled substances. The Pharmaceutical Chemist performs routine and non-routine quality control testing of raw materials, in process, residual, finished product, and stability testing within the framework of the site policies and cGMP regulations. Participates in special studies to accomplish company and departmental goals. Records and reports data accurately and in compliance with current methods/SOPs, USP/NF, other compendia as applicable, and cGMP. Performs duties under the guidance of laboratory management or designee. Mentors junior analysts to develop their technical competence.
Bachelor’s Degree in Chemistry or related science field is required with 4 years of pharmaceutical experience in a professional setting is preferred (university internships do not meet this criteria).
To perform this job successfully, an individual should have competent computer skills including knowledge of Word, Excel, Access, Outlook, and ability to use internet tools. Empower Chromatography software experience is highly desirable.
Apply to email@example.com or fax to 423-989-8042, Gregory Pharmaceutical Holdings, Inc., 501 5th St., Bristol, TN 37620.