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 email@example.com to discuss our current open positions.
UPM offers competitive salaries and an excellent benefit package.
Current Open Positions at UPM Pharmaceuticals (14 Nov 2019)
Manager, Laboratory Investigations
The Manager of Laboratory Investigations is responsible for coordinating training for and managing the QC Lab Investigations program. To fulfill this role, the ideal candidate would:
- Be SME of Lab Investigations providing leadership, technical and quality support. This would involve training supervisor/management staff of each department subgroup proper root cause analysis and/or hone investigational skills.
- Assist teams in conducting and push for timely investigations
- Be responsible for ensuring lab investigations and results generated are in conformance with product quality, in compliance with company SOPs, and meet appropriate federal and foreign regulations (as applicable)
- Fully understand all regulatory body requirements and how they pertain to the Quality Department and client’s products.
- Must be comfortable, professional, and communicate very well with auditors during inspections or with company’s clients when problems arise. Must be a good negotiator and able to come to compromise within confines of regulatory requirements.
- Interact well with functional peer group managers.
- Create and manage key performance indicators and metrics for the investigational process.
- Be able to use information identified in investigations to suggest continuous improvement or training activities to prevent future problems.
- Be quality focused in a fast-paced, dynamic work environment through understanding and rigorous application of quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP) within the department.
- Have very strong technical writing skills.
- Review, approve and provide technical guidance for all laboratory investigations.
- Prepare work schedules for and maintain accountability of direct reports
Required: Minimum BS degree in an appropriate Scientific discipline (Chemistry- highly preferred, Biology, etc.). At least, 8-10 years of professional experience in pharmaceutical manufacturing, Quality Control/Assurance, or related field which may include supervisory experience. Strong understanding of laboratory investigations and regulatory expectations for QC Laboratories as well as strong demonstrated performance of prior experience in laboratory investigations is mandatory. Alternate combinations of education and experience may be considered.
The Manufacturing Operator performs manufacturing processes of solid dose tablets and capsules, and liquid dose, in accordance with SOPs, approved batch records, and cGMP procedures.
Essential Duties and Responsibilities:
- Weighs and samples development and commercial manufacturing batches in accordance with applicable SOPs.
- Sets up, operates, breaks down and cleans equipment to be used in manufacturing activities in accordance with SOPs and equipment specifications.
- Performs scheduled manufacturing activities in accordance with approved batch records.
- Performs appropriate in-process tests of manufactured products during the manufacturing process.
- Provides appropriate documentation of manufacturing processes and test results including maintaining and reconciling equipment and room use log books, batch records, and inventory records in accordance with SOPs.
- Performs appropriate cleaning of equipment and the facility in accordance with SOPs and cGMP procedures.
- Troubleshoots equipment/processes during the manufacturing process.
- Performs other duties as assigned.
Knowledge Necessary to Perform the Job:
- Moderate knowledge of cGMP practices required.
- Moderate knowledge of operation of technical equipment required.
- Knowledge of processes related to the production of solid dose pharmaceutical manufacturing REQUIRED.
- Knowledge of process related to the production of liquid dose pharmaceutical manufacturing required.
- Knowledge of electronic data acquisitions systems to include ADP, Documentum, and FormWeigh.
High School Diploma or GED required.
Chemist I, II
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 compendium 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.
- Preforms 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 compendium as applicable,and cGMP. Performs duties under the guidance of laboratory management or designee.
To qualify for a Chemist I - Bachelor’s Degree in Chemistry or related science field is required with 2 years of pharmaceutical experience in a professional setting is preferred (university internships do not meet this criteria).
To qualify for a Chemist II - 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).
Manager of Quality Systems
Under management of quality assurance leadership, directs and performs activities ensuring quality assurance, cGMP, regulatory agency, and internal SOP compliance support for pharmaceutical projects.
Essential Duties and Responsibilities:
- Perform internal and external audits of GMP systems.
- Manage quality metrics program, develop key process indicators and provide reports to company management.
- Lead cross functional teams to complete annual product reviews.
- Serve as lead author and/or reviewer of investigations, deviations, laboratory investigations, customer quality audits, product complaints and change controls related to the site.
- Review batch records and laboratory analytical reports for accuracy and compliance with cGMP and company SOPs prior to allowing formal company release of manufacturing activity or products.
- Review laboratory and manufacturing specifications, equipment qualifications, validation protocols and reports for accuracy and compliance with cGMP, and company SOPs.
- Provide timely and effective updates and communication to management relative to audit results, organization compliance to cGMPs and other quality efforts.
- As required, host client and/or Regulatory Agency audits and provide feedback on client contract proposals concerning scope of work and costs.
- Provide assistance with the oversight of the calibration and maintenance program for manufacturing equipment, instrumentation, and measuring devices.
- Assist in maintaining all regulatory, compliance documents, and CAPAs.
- Provide cGMP training to personnel.
- Write and revise company Standard Operating Procedures (SOPs).
- Assist in ensuring compliance with all safety and environmental requirements associated with the manufacturing and laboratory activities.
- Performs other duties as required.
- Bachelor’s degree in Chemistry, engineering or related scientific field. Advanced degree preferred. Equivalent combination of education and experience or training is acceptable. At least 10 years of experience in Quality Assurance management in a GMP pharmaceutical manufacturing environment. Equivalent combination of education and experience or training is acceptable.
- Expert knowledge of FDA regulations 21 CFR Parts 210 & 211, and ICH Guidelines
- Expert knowledge of oral dose and semi-solid manufacturing processes essential.
- Knowledge of QC inspection and QC lab processes.
- Knowledge of analytical test methods (HPLC, dissolution, content uniformity).
- Knowledge of validation requirements (equipment, process, software).
To apply, send resume and salary requirements to: firstname.lastname@example.org