Manufacturing Associate - Nights

Role Summary

Manufacturing Associate will operate and maintain manufacturing equipment on the Night shift (6pm–6am ET) on a rotating 2/2/3 schedule. The role includes performing in-process quality checks, recording manufacturing and inspection data, completing required SOP and cGMP documentation, performing set ups and changeovers, cleaning the work area, and contributing to process improvements.

Responsibilities

• Operates and ensures proper operation of manufacturing equipment.
• Conducts regular in-process checks of quality attributes of materials and products to ensure 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 to implement improvements to the process, productivity, quality and reduce costs.
• Performs other related duties as assigned.

Qualifications

• Required: 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.
• Required: Requires ability to follow standard work and Standard Operating Procedures (SOPs).
• Required: Basic computer skills and the ability to navigate through computer based training systems and use in the course of daily work may be required.
• Required: Must be able to communicate effectively as a member of a work team.
• Required: Must meet all locally defined training requirements.
• Preferred: Experience in a pharmaceutical, FDA-controlled, other controlled regulatory agencies, or Current Good Manufacturing Practices (cGMP) packaging or manufacturing environment.
• Required: Required to operate and handle material handling equipment.
• Required: Ability to work overtime as required.

Skills

• Ability to follow procedures and SOPs precisely in a cGMP environment.
• Effective communication and teamwork.
• Basic data recording and documentation accuracy.
• Proficiency with basic computer systems used for training and documentation.

Education

• High School Diploma or Equivalency required.

Additional Requirements

• Physical Requirements: Sit, walk, lift 50 lbs regularly; push/pull, grasp, move items; occasional standing, climbing stairs/ladders, stooping/bending, squatting, kneeling, twisting, reaching above shoulders and head; rarely lift 25 lbs above shoulders.
• Environmental: Exposure to loud noises/machinery and chemicals; occasional hot conditions with temperatures 90+ degrees Fahrenheit.
• Other Qualities: Vision and color perception, hearing, reading/writing in English, basic math; ability to interpret information; simple problem solving and decision-making based on SOPs and data readouts.