Manufacturing Operator III in Bristol, Tennessee at Gregory Pharmaceutical Holdings Inc

Job Title: Manufacturing Operator III

Reports To: Associate Director, Manufacturing

Department: Manufacturing

FLSA Status: Non-Exempt

Location: Bristol, TN

Prepared By/Date: Kevin Watkins / 24JUN20

Approved By/Date: Tyler Ewald / 24JUN20

Summary: 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:

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.

Knowledge Necessary to Perform the Job:

1. Knowledge of CFR 210 & 211 cGMP’s required.
2. Knowledge of operation of technical equipment required.
3. 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.
4. Knowledge of electronic data acquisitions systems to include Microsoft Office, ADP, Documentum, and FormWeigh.

Competency:

To perform the job successfully, an individual should demonstrate the following competencies:

Problem Solving: Identifies problems and notifies appropriate supervisors to resolve situation in a timely manner.

Technical Skills: Ability to operate solid dose manufacturing equipment including, but not limited to tablet presses, encapsulators, fluid bed systems, blending equipment, and spray coaters.

Teamwork: Ability to complete assigned activities.

Oral Communication: Communicates clearly and with respect when dealing with other department members.

Written Communication: Completes documents/logs clearly and accurately.

Ethics/Professionalism: Works with integrity and ethically maintains confidentiality. Projects a professional and courteous business demeanor.

Organizational Support: Supports organization’s goals and values. Follows policies and procedures.

Adaptability: Ability to deal with frequent changes to schedules, delays, or unexpected events.

Attendance/Punctuality: Must be present daily, on time, as scheduled. Must communicate attendance issues with Director of Manufacturing prior to scheduled start, using appropriate means.

Initiative: Demonstrate ability to strive for process related and personnel improvement.

Quality: Observes company quality policies and procedures.

Safety and Security: Observes safety and security procedures and notifies proper personnel when safety concerns are encountered.

Qualifications:

The requirements listed below are representative of the knowledge, skill, and/or abilities required of the position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education/Experience: 10 years experience in a manufacturing / packaging environment, or 7 years of applicable pharmaceutical experience. High School diploma or general education degree (GED) is required. Experience working with solid dose and semi-solid manufacturing equipment and processes is desirable.

Language Ability: Ability to read and interpret documents such as safety rules, operating and maintenance control instructions, SOPs, batch records, procedures manuals, and packaging records. Ability to complete batch records and other control records.

Math Ability: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to conduct reconciliations, match counts and computations of production runs.

Reasoning Ability: Ability to think independently and prudently, and to produce quality products that impact the lives of others.

Computer Skills: To perform this job successfully, an individual should have basic computer skills with knowledge of Word, Excel, Access, Outlook and ability to use internet tools.

Work Environment and Physical Demands: The work environment characteristics and physical demands described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in this work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand, walk, sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and talk or hear. The employee must frequently work around equipment with moving parts. The employee must frequently lift and/or move up to 25 pounds, and occasionally lift and/or move up to 50 pounds independently, and over 50 lbs with assistance. Specific vision abilities required by this job include ability to adjust focus and distinguish color.