Manufacturing Operator

Manufacturing Operator

Function: Efficiently, effectively, and safely clean, set-up, and operate machinery in the oral solid dose area to manufacture tablets meeting FDA and company standards of quality and productivity while adhering to applicable cGMPs and SOPs including following written instructions and properly documenting the process.

Primary Responsibilities and Essential Functions of the Position:

• Follow Master Batch Records for the manufacturing of controlled oral solid dose products.
• Responsible for raw materials, blends, and bulk accountability throughout manufacturing processes.
• Responsible for packaging of oral solid dose products and manufacturing/packaging of other oral/topical dosage forms according to the Master Batch records, when required.
• Identify, report, and resolve quality issues.
• Safely and in compliance with batch records and SOPs, set up, operate, and clean manufacturing and packaging equipment (oral solid dose manufacturing may include rotor sieves, granulators, blenders, coaters, encapsulators, compression machines, etc.).
• Perform in-process testing and inspections as required by Master Batch Record (weighing, tablet thickness, tablet hardness, friability, visual inspection, etc.).
• Cleaning and sanitization of manufacturing rooms including walls, floors, and ceilings per SOPs.
• Report accidents and unsafe conditions or unusual circumstances to supervisor.
• Follow good documentation practices.
• Handling labeling and components correctly; transferring, counting, FIFO, returns, etc. during packaging processes.
• Assemble, seal, and stack shippers on a skid.
• Maintain a neat and orderly work area.
• Maintain documentation of log books and batch records while maintaining GDP.
• Other duties, which may be assigned from time to time.

Skills and Abilities Required:

• Current GMP training.
• Capability to perform basic mathematical computations of addition, subtraction, multiplication, and division.
• Strong attention to detail and ability to write and record data legibly and accurately.
• Ability to understand and follow Master Batch Records and Standard Operating Procedures (SOP’s).
• Ability to work both independently and within a team.
• Ability to operate manual pallet jacks.
• Good interpersonal and communication skills.

Minimum Education and Experience Required:

• High School Diploma or equivalent.
• 1-3 years’ experience working in a GMP manufacturing environment
• Experience in a regulated industry preferred

Physical Requirements:

• Ability to lift up to 35 pounds multiple times per day.
• Ability to stand for long periods of time (8-10 hrs./day; 4-6 days/week)
• Ability to read very small print.

Job Type: Full-time

Pay: $12.18 - $21.19 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Fenton, MO 63026: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

Salary : $12 - $21