Manufacturing Associate - 2nd Shift

Job Description Summary

Processes active compound materials into final tablet form performing quality control checks to maintain consistency of product according to manufacturing specifications.

Executes all Production processes while strictly adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines and any other related regulations that could apply.

The Manufacturing Associate is expected to fully participate in both departmental projects and any quality working teams that may be applicable.

Supports the leader and subject matter (SME) expert in their area(s) of responsibility.

Supports production, operations projects and process improvements.

Maintains accurate and compliant documentation on all activities.

• Obtain and weigh in products for all shifts.
• Moves raw materials and product to/from vault, cage, process or storage areas.
• Inspects machine parts for unusual wear and proper lubrication.
• Operates equipment required in the manufacture of pharmaceutical product.
• Performs and reviews quality checks on weight, thickness, hardness and friability of tablets at various stages of the process according to manufacturing instructions and SOPs.
• Submits product samples to quality laboratories as required.
• Maintains product batch, room activity, and equipment records.
• Maintains control of DEA‑scheduled material in accordance with accepted policy, practice and procedure.

Achieved to Standards. Is at his/her position on the line ready to start production as required.

Monitors the production process, makes periodic checks and adjusts equipment or work practices to maximize production efficiency, yields, quality and safety.

Accurately reports production and ensures reports are completed as required.

Performs operator‑level machine adjustments and lubrication.

Assists technicians with minor machine repairs and set‑up.

Troubleshoots problems with equipment and processing to assist other technicians to minimize disruptions to production.

Ensures that line conditions are acceptable to change from one product to another by ensuring that materials, paperwork, and equipment have been staged for changeover.

Will immediately stop manufacturing and notify Line Leader of any safety or quality concerns.

Documents inspections performed and keeps accurate equipment records, clean‑up sheets and other required paperwork.

Disassembles, cleans and reassembles basic line equipment according to SOPs.

Insures proper inspections are conducted prior to reassembly.

Cleans and assembles dust collector.

Assists in the training of individuals on equipment and processes in the department.

Follows all EHS rules and regulations.

Accepts accountability for own personal safety and identifies potential unsafe conditions to help prevent self and co‑workers from being injured.

Complies with all site security requirements.

Performs lock‑out/tag‑out procedures according to SOPs.

Follows safe working practices in the execution of their assigned duties.

Collects all process related hazardous wastes and transports to accumulation drums.

Actively participates in general site and departmental Safety initiatives.

Maintains clean work area; clear away debris, damaged or defective product, cartons, labels and packaging supplies.

Adhered to. Makes initial attempts to identify root cause within scope of decision‑making authority while simultaneously notifying next level of leadership.

If attempts at the next level do not resolve the problem and the Associate believes that a higher level needs to be involved, the problem is escalated to the highest level.

Assists technicians at other stations within the department as needed.

Works on any tableting stations on which you are trained.

May be cross‑trained in other functions.

Education:

• Requires the basic knowledge and ability to apply mathematical concepts, spelling, reading English, and grammar.
• Requires a High School diploma or GED.

Experience:

• Recommended minimum of three to twelve months’ experience under…