Pharmaceutical Industry Careers

Qualified candidates must be legally authorized to be employed in the United States. UPM does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

To ensure manufacturing rooms and equipment are cleaned to meet cGMP standards. Ensure washrooms, hallways, and gowning areas are routinely cleaned and cleaning appropriately documented. Perform inspections/verifications of clean equipment and rooms to ensure quality standards are met. Perform and document room clearances to mitigate the risk of product cross-contamination. Work with Manufacturing Operators to perform periodic checks for production in-process.

Essential Duties and Responsibilites

1. Clean manufacturing equipment and rooms.
2. Clean common areas on the production floor including washrooms, hallways, and gowning areas.
3. Perform equipment cleaning verifications.
4. Perform clearances of rooms and equipment.
5. Ensure all cleaning agents used are properly labeled.
6. Ensure training remains current.
7. All other duties as may be assigned.

Education/Experience:

High School Diploma or GED equivalent.

The Manufacturing Operator performs manufacturing processes of solid dose tablets and capsules, and semi-solids, in accordance with SOPs, approved batch records, and cGMP procedures.

Essential Duties and Responsibilites

1. Weighs and samples development and commercial manufacturing batches in accordance with applicable SOPs.
2. Sets up, operates, breaks down and cleans equipment to be used in manufacturing activities in accordance with SOPs and equipment specifications.
3. Performs scheduled manufacturing activities in accordance with approved batch records.
4. Performs appropriate in-process and verification tests of manufactured products during the manufacturing process.
5. 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.
6. Performs appropriate cleaning of equipment and the facility in accordance with SOPs and cGMP procedures.
7. Troubleshoots equipment during the manufacturing process.
8. Performs departmental training on equipment and processes.
9. Performs other duties as assigned.

Education/Experience:

• To qualify for an Operator II- High School diploma or general education degree (GED) is required. 2-5 years’ experience working with solid dose and or liquid manufacturing equipment and processes.
• To qualify for an Operator III- High School diploma or general education degree (GED) is required. Five plus years primary experience working with solid dose and or semisolid manufacturing equipment and processes required
• Qualified candidates must be legally authorized to be employed in the United States. UPM does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Knowledge Necessary to Perform the Job:

• Knowledge of CFR 210 & 211 cGMP’s required.
• Knowledge of operation of technical equipment required.
• Knowledge of processes related to the production of solid dose and semi-solid pharmaceutical manufacturing required and/or knowledge of process related to the production of semi-solid dose pharmaceutical manufacturing required. Processes may include but not limited to blending, granulation, compression, encapsulation, and / or coating.
• Knowledge of electronic data acquisitions systems to include Microsoft Office, ADP, Documentum, and FormWeigh.

UPM Pharmaceuticals, Inc., (www.upm-inc.com), a contract drug development and manufacturing company for the pharmaceutical industry, located in Bristol, Tennessee, is seeking a Quality (MQA) Specialist (Floor) I, II or III.

Essential Duties and Responsibilities:

1. Becomes proficient in the manufacturing operations and quality procedures for the area (s) to facilitate compliance to regulations.
2. Assists and supports the manufacturing and packaging staff in detecting and solving compliance errors in real time during operations.
3. Participates in understanding failures and resulting corrective and preventative actions (CAPAs) through notice of event reports.
4. Reports to management any observed NOEs for procedural deviations.
5. Performs manufacturing and packaging room inspections.
6. Performs cleaning data and equipment inspections.
7. Reviews manufacturing and packaging batch records real time.
8. Assess work orders and provide quality concerns as it relates to the work being performed.
9. Compiles data for monthly metrics.
10. Understands and follows current Good Manufacturing Practice regulations.
11. Recognizes and reports problems and adverse quality events to quality management.

Education/Experience:

• To qualify for a MQA Floor I - Bachelor’s Degree is required with 0 – 2 years of related experience and/or training; or equivalent combination of education and experience.
• To qualify for a MQA Floor II - Bachelor’s Degree is required with 2 – 4 years of related experience and/or training; or equivalent combination of education and experience.
• To qualify for a MQA Floor III - Bachelor’s Degree is required with 4 - 6 years of related experience and/or training; or equivalent combination of education and experience.

Position with training in statistical sampling and inspection of bulk materials, packaged products and processes for conformance to approved written specifications, SOP's, cGMPs, and FDA regulations. Requires physical testing training. Is able to perform sampling and inspection with minimal supervision .

Qualified candidates must be legally authorized to be employed in the United States. UPM does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Essential Duties and Responsibilities:

• 1. Performs manufacturing room inspections, in-process checks, cleaning verifications and raw material verifications for all drug products and manufacturing operations.
• 2. Performs in-process inspections, labeling verifications, line clearances, and cleaning verifications on all packaging operations.
• 3. Reports any problems found during inspections to Quality Assurance management.
• 4. Follows cGMP documentation practices in manufacturing and packaging records.
• 5. Reviews manufacturing and packaging batch records.
• 6. Understands and recognizes product status such as Approved, Hold, Rejected, etc.
• 7. Understands and follows current Good Manufacturing Practice regulations.
• 8. Understands and utilizes ANSI sampling plans.
• 9. Recognizes and reports problems and adverse quality events to quality management.
• 10. Other job duties as assigned.

Knowledge Necessary to Perform the Job:

• 1. Knowledge of 21 CFR Parts 210 and 211.
• 2. Knowledge of all applicable quality, manufacturing, packaging, and multi departmental SOP's in order to perform duties.

Education/Experience

• SQC Inspector I: HS/GED 3 years or more related experience and/or successful completion of a job specific training program or equivalent combination of education and experience.
• SQC Inspector II: HS/GED and 5 or more years related experience and/or successful completion of job-specific training program or equivalent combination of education and experience.

What we offer you

• Leading pay for all positions
• All employees enjoy generous paid time off including 11 paid holidays
• 17 paid PTO days
• Health Insurance, Dental Insurance, Vision Insurance – effective day one with low-cost premiums available for single or family coverage
• Company paid employee assistance program
• 4% 401K company match
• Company paid life insurance, long term and short-term disability
• Many discounts on products and services made available to employees
• Employee Referral Awards
• Onsite fitness center
• Relocation assistance

This position is responsible for supporting both Production Maintenance and Facilities Maintenance operations, with a focus on minimizing equipment downtime through the effective coordination of parts and supply inventories. Key responsibilities include managing the spare parts room, maintaining appropriate stock levels of maintenance and critical spare parts, and driving continuous improvement in spare parts availability and cost efficiency. The role also assists in project planning activities, which may include obtaining price quotations, maintaining equipment inventory records, and issuing necessary parts.

UPM Pharmaceuticals is an independent, highly experienced, and award-winning contract development and manufacturing organization (CDMO) located in Bristol, Tennessee. UPM Pharmaceutical’s mission is to advance Client formulation development efforts to the fullest extent possible with the ultimate goal of commercialization, all while adhering to strict standards of quality, timeliness, scientific fundamentals, and affordability.

Qualified candidates must be legally authorized to be employed in the United States. UPM does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Essential Duties and Responsibilities:

• 1. Maintain stock levels for repair / maintenance parts, including descriptions, stock, and location for all parts in Enterprise Asset Management System.
• 2. Establish and maintain min. / max. reorder points and planning parameter data for effective inventory management (spare parts & supply inventory).
• 3. Contact vendors as needed to obtain price quotes, follow up on part orders and set up service requests.
• 4. Assures the availability of parts in a cost-effective manner.
• 5. Familiarity with a GMP environment.
• 6. Receive, tag, stock and dispense parts to technicians.
• 7. Track all parts entering and leaving the parts room using Enterprise Asset Management System.
• 8. Issue and maintain accountability of tools used for repair of equipment.
• 9. Administrative duties such as purchase order generation and tracking, spare parts inventory, maintenance supply replenishment, work order tracking and documentation maintenance.
• 10. Assist service technicians in determining parts & accessories requirements for individual jobs.
• 11. Notify service personnel when special parts or back-ordered parts are received.
• 12. Maintain cleanliness of Parts and Accessories Department and keep inventory neatly stacked and orderly.
• 13. Other duties as may be assigned.

Education/Experience:

• Associates degree required. 3 – 5 years’ experience in parts / inventory management desired. An equivalent combination of professional work experience and related education will be considered in place of a degree.

Performs routine microbiological quality control testing of pharmaceutical products and related materials in accordance with site policies, departmental procedures, compendial methods, and cGMP regulations. Assists in special testing studies of experimental, investigative, validation studies and problem solving nature. Participates in programs to achieve departmental objectives; records and reports results; notes unusual results and notifies supervisor for evaluation. This position requires a continuation of training and learning to become proficient with routine testing procedures, compendial methods, cGMP and associated SOPs. 

UPM Pharmaceuticals is an independent, highly experienced and award winning contract development and manufacturing organization (CDMO) located in Bristol, Tennessee. UPM Pharmaceutical’s mission is to advance Client formulation development efforts to the fullest extent possible with the ultimate goal of commercialization, all while adhering to strict standards of quality, timeliness, scientific fundamentals, and affordability. Currently, UPM is accepting open applications for a Microbiologist I, II.

Essential Duties and Responsibilities:

• 1. Performs routine microbiological testing of raw material, in-process, finished product and stability following approved specification and Standard Operating Procedures (SOPs). This may include but is not limited to antibiotic testing, bioburden/microbial limit testing, antimicrobial effectiveness testing, water testing, environmental monitoring, microbial isolation and identification technique, sterility and endotoxin testing.
• 2. Completes testing with a high degree of efficiency, reliability and accuracy.
• 3. Maintains the Microbiology Laboratory. This may include but is not limited to maintenance, calibration and use of standard laboratory equipment.
• 4. Logs samples received into the laboratory to assess their integrity upon receipt.
• 5. Performs assigned work in timely and safe manner conforming to regulatory, company and compendial requirements.
• 6. Records and reports test data correctly, completely and accurately within company and departmental policies and guidelines. Notifies supervisor of unusual results for evaluation.
• 7. Actively assumes and demonstrates responsibility in learning practical laboratory skills and a thorough knowledge of microbiological theories, methodologies and procedures.
• 8. Acquires complete knowledge and understanding of company and departmental policies pertaining to cGMP, cGLP, safety, health, security and departmental operation. Complies with company and departmental regulations, policies and guidelines in performance of the job.
• 9. Recognizes problem within scope of the job and promptly and clearly communicates them to supervisor. Follows directions and demonstrates proper judgment when a deviation occurs.
• 10. Initiates Laboratory Investigations (LIR) and Notices of Events (NOE). Reviews OOS and unusual test/equipment data with management or senior staff. Completes LIR or NOE under the direction of management and advisement of more experienced laboratory staff
• 11. Recognizes trends, deviations, problems and promptly reports them to laboratory management. Follows directions and demonstrates proper judgment when a deviation occurs.
• 12. Participates in inventory control. Maintains a neat and orderly workplace, adhering to all laboratory disinfection policies.
• 13. Assist in performing experiments related to problem solving for the Microbiology department, under the direction of more experienced analysts and/or laboratory management.
• 14. Trains less experienced employees on new methods or procedures in the lab, under the direction of laboratory management.
• 15. Assists in microbial method validation, coordinates the materials required for method, process and system validations as under the direction of more experienced analysts and/or laboratory management.

Education/Experience:

• Microbiologist I - Bachelor’s Degree in Microbiology or related science field and 0-2 years of related experience; or an equivalent combination of education and experience/training; advanced degree in Microbiology or closely related field is desirable, but not required; some laboratory experience is desirable.
• Microbiologist II - Bachelor’s Degree in Microbiology or related science field and 2 to 4 years related experience; or an equivalent combination of education and experience/training. Bachelor’s Degree in Microbiology or related science field and 2 to 4 years related experience; or an equivalent combination of education and experience/training.

Set-up, operate, adjust, and disassemble pharmaceutical packaging machinery from the most basic functions to the most complex functions of the associated equipment. Perform routine preventative maintenance (PMs), troubleshooting, and repair of packaging equipment in the packaging department in accordance with SOPs and cGMP procedures. 

UPM Pharmaceuticals is an independent, highly experienced, and award-winning contract development and manufacturing organization (CDMO) located in Bristol, Tennessee. UPM Pharmaceutical’s mission is to advance Client formulation development efforts to the fullest extent possible with the ultimate goal of commercialization, all while adhering to strict standards of quality, timeliness, scientific fundamentals, and affordability.

Qualified candidates must be legally authorized to be employed in the United States. UPM does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Essential Duties and Responsibilities:

• 1. Perform set-ups of packaging equipment in accordance with SOPs and equipment specifications.
• 2. Operate equipment and adjust as necessary to achieve batch record parameters.
• 3. Provide recommendations for operating parameters for new projects/products.
• 4. Disassemble machinery and equipment to remove parts for cleaning or repair.
• 5. Perform room and equipment clearance inspections as required
• 6. Examine parts for defects such as breakage and excessive wear.
• 7. Troubleshoot and identify mechanical root causes of packaging defects.
• 8. Repair and replace broken or malfunctioning components of machinery.
• 9. Perform routine Preventative Maintenance (PMs) of machinery.
• 10. Reassemble equipment for the entire packaging process after completion of cleaning inspections, PMs, testing, or repairs.
• 11. Assist maintenance personnel in repair of equipment.
• 12. All other duties as assigned.

Education/Experience:

• Two year certificate from a technical college or vocational school preferred or a high school diploma or equivalent and 3+ years of experience with a strong mechanical background. Experience troubleshooting motor controls, programmable logic controllers (PLC’s), CompactLogix controllers, and a working knowledge of engineering drawings, electrical schematics, and engineering flow diagrams preferred. General knowledge of Pharmaceutical manufacturing or experience in a regulated industry preferred. Equivalent combination of education and experience or training is acceptable.

The role will be responsible for the planning and management of production material needs in conjunction with production schedule and forecast(s). 

Qualified candidates must be legally authorized to be employed in the United States. UPM does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

UPM Pharmaceuticals is an independent, highly experienced, and award-winning contract development and manufacturing organization (CDMO) located in Bristol, Tennessee. UPM Pharmaceutical’s mission is to advance Client formulation development efforts to the fullest extent possible with the ultimate goal of commercialization, all while adhering to strict standards of quality, timeliness, scientific fundamentals, and affordability.

Essential Duties and Responsibilities:

1. Coordination and maintenance of product specific inventory spreadsheets.
2. Obtains list of open purchase orders and evaluates production material needs, specific to anticipated manufacturing/packaging dates.
3. Coordinates with purchasing department to ensure needed materials are on order with specific attention to estimated lead times for the specific materials.
4. Partnering with project managers and production planner to identify material needs and current projected forecasts.
5. Monitoring and tracking of materials received to ensure they’re tested and released in time to meet production schedule needs.
6. Monitoring of executed batches and resulting internal inventory while accounting for future material needs.
7. Communicates issues with leadership and departmental management that could cause delays in production or opportunities to improve delivery dates to our clients.
8. Communicates with various internal units and resolves concerns regarding schedules, orders, and special needs.
9. Generates and publishes daily/weekly/monthly reports on current inventory and anticipated ordering needs.
10. Coordinate with raw materials lab to schedule testing of incoming materials for production.
11. Coordinate with QA to schedule sampling activities and release of tested materials for production.
12. Attend client meetings as necessary to communicate status of materials/needs.
13. Perform other duties as required.

Education/Experience:

1. Bachelor Degree in a business related area, Logistics, Engineering preferred.
2. 5+ years’ experience in a planning/project management role required.
3. Minimum of 3 yrs. experience in a pharmaceutical manufacturing environment is required.
4. Equivalent combination of education or training is acceptable.