JOB PURPOSE & SUMMARY OF POSITION
Assist in the accurate and efficient manufacturing of Active Pharmaceutical Ingredients (APIs) in support of the business unit while meeting local, state, and federal quality and safety regulations. Operate and monitor production equipment. Learn to develop individual work plan with the help of the Shift Leader to meet production schedules. Complete batch records in accordance with FDA and Current Good Manufacturing Practice (cGMP) guidelines and business unit Standard Operating Procedures to ensure batch quality and integrity. Maintain a safe and clean operating area according to safety and quality policies/procedures.
- Demonstrates technical proficiency and self-assuredness in applying cGMP standards.
- Applies cGMP concepts in association with department specific responsibilities and assist in the training of less experienced team members on these concepts.
- Ensures all documentation produced is in compliance with cGMP standards including good documentation practices. This includes the timely completion of data entry. It also includes accuracy of manufacturing batch records, cleaning logs and labeling of in-process materials and equipment. Review of process documentation when complete to ensure closure in a timely manner.
- Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed. Contributions include daily cleaning, identification of continuous improvement areas, general area cleanliness, parts/equipment organization, etc.
Ensures work is in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc.
ENVIRONMENTAL, HEALTH, & SAFETY RESPONSIBILITIES
PHYSICAL DEMANDS & WORK ENVIRONMENT
- While performing the duties of this job it is required to stand, walk, and use hands to operate objects, tools, or controls; reach with hands or arms; climb, balance, stoop, kneel, or crouch when necessary for job activity.
- Must be able to lift and/or move up to 50 pounds and occasionally lift and/or move more than 100 pounds using available material handling equipment.
- Regularly works with moving mechanical parts and may work with toxic or caustic chemicals. The work may be performed in humid areas with low or high temperatures.
- The noise level in the work environment is usually moderate, but can vary depending on the area where work is being performed/supervised/analyzed.
- Travel between the two Johnson Matthey Pharma Services locations may be required.
- 12-hour day and night rotating shift schedule. At times overtime may be required.
QUALIFICATIONS, KNOWLEDGE, & EXPERIENCE
High School Diploma or equivalent with 2-4 years of experience in pharmaceutical production and/or chemical engineering environment.
Bachelors Degree in Chemical Engineering or related field and 0-2 years of experience in pharmaceutical production and/or chemical engineering environment.
Ability to apply scientific and/or technical knowledge in the performance of job duties.
Ability to use a forklift. (Some experience preferred).
Demonstrate attention-to-detail, problem solving, and ability to multi-task.
Good written and verbal communication.
Experience participating in a team work environment.
Experience with Microsoft Office and other job-related software.
Good understanding of GMPs and FDA regulations.
Experience with glass lined reactors, Nutsche Filters, air driven diaphragm pumps, ovens, and vacuum pumps.