Manufacturing Associate - Days

Role Summary

Manufacturing Associate for the Day shift (6:00 a.m. to 6:00 p.m. ET) on a rotating 2/2/3 schedule. Responsibilities include operating and ensuring proper operation of manufacturing equipment, performing in-process quality checks, and maintaining production and inspection records in compliance with SOPs and cGMPs. The role requires following standard work and collaborating with team members to support process improvements and efficient production.

Responsibilities

• Operates and ensures proper operation of manufacturing equipment.
• Conducts regular in-process checks of quality attributes of materials and products to ensure the equipment is operating correctly.
• Assists in recording accurate production and inspection data and completes manufacturing paperwork in compliance with required SOPs and cGMPs.
• Performs set ups, changeovers and cleans the work area throughout the shift to ensure proper clearance of materials.
• Continuously looks for and helps implement improvements to the process, productivity, quality and to reduce costs.
• Performs other related duties as assigned.

Qualifications

• High School Diploma or Equivalency required.
• Must possess basic math and reading comprehension skills and be able to read, speak and comprehend instructions in English, including procedure documents, as well as proofread alpha and numeric data.
• Ability to follow standard work and Standard Operating Procedures (SOPs).
• Basic computer skills and the ability to navigate through computer based training systems and use in the course of daily work may be required.
• Must be able to communicate effectively as a member of a work team.
• Must meet all locally defined training requirements.
• Experience in a pharmaceutical, FDA controlled, or other regulated cGMP packaging or manufacturing environment is preferred.
• Required to operate and handle material handling equipment.
• Ability to work overtime as required.

Education

• High School Diploma or Equivalency.

Additional Requirements

• Physical requirements: Consistently/Frequently – sit, walk, lift 50 lbs., pulling and pushing, grasp, move items, and feel with hand/fingers; Occasionally – stand, climb stairs/ladders, stoop/bend, squat, kneeling, twisting, reach, reach above shoulders and head; Rarely – lift above shoulders and head 25 lbs.
• Environmental: Consistently/Frequently - exposure to loud noises/machinery and exposure to chemicals; Occasionally - exposure to hot conditions including room temperatures of 90+ degrees Fahrenheit.
• Other Qualities: Vision, color vision, hearing, ability to read and write, ability to interpret information, basic math, reading and writing in English; simple problem solving and decision-making may be required to adjust process parameters and document corrections to batch records and other controlled documents using cGMP-compliant practices.