Formulation and Packaging Manufacturing Associate

Job Description:

This position is responsible for producing several Immucell products according to the batch records and supportive procedures. Other duties include raw material weighing/dispensing and inventory management, cleaning, disinfection and bulk material movement. The position reports to the Production Coordinators.

Primary Responsibilities:

· Operate capsule filling, heat sealing/die cutting, compounding/gel filling, labelling and packaging machines according to approved records and procedures.

· Document required process information in the batch record or log books, including timely documentation at the time of step execution.

· Operate glasswasher, pH meters, balances, cold rooms, refrigerators and freezers and document according to the approved procedure.

· Conduct review of records, logs, procedures and other documentation for accuracy and completeness.

· Conduct or participate in process and equipment investigations and deviations, validations, trending, and improvements.

· Participate in self-audits of the manufacturing areas to continue to meet regulatory standards and commitments.

· Clean, disinfect and maintain manufacturing process equipment and room surfaces.

· Adhere to approved procedures, regulatory filings and commitments using Good Documentation Practices compliant with USDA regulations and cGMPs (ICH Q7 and Part 210.211).

· Strict adherence to OSHA/PPE requirements is mandatory.

· Conduct component and supply inventory counts and make recommendations for procurement.

· As applicable, USDA training for sampling may be required.

· Other duties as required.

· Strong communication, interaction and teamwork skills are required as most duties are performed by small teams.

Qualifications:

· High school diploma or GED or equivalent combination of experience and education.

· Associate’s or Bachelor’s degree in a science or engineering discipline is a plus.

Preferred Additional Qualifications:

· cGMP experience at a USDA or FDA regulated facility.

· Experience working in aseptic clean rooms.

· Forklift/electric pallet jack experience preferred but not required.

· Experience with automation systems (including HMI’s and/or PLC’s).

· Computer skills in drafting reports, deviations and investigations as well as trending.

Physical Demands:

· Frequently required to walk and use hands and fingers to handle objects, tools or controls.

· Frequently required to stand, reach with arms and hands, climb or balance, stoop, kneel, crouch or crawl.

· Frequently lift and/or move up to 60 pounds or greater (with assistance).

· Frequently move 55-gallon drums on drum dollies and pallets of material with pallet jacks.

Job Type: Full-time

Expected hours: 40 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person