Position Summary
The Packaging Operator is responsible for operating blister carding machines to seal tablets and capsules into aluminum/PVC blister packs, inserting blister packs into retail display cards, and packing finished products into cases and shipping containers. This role requires strict adherence to FDA Current Good Manufacturing Practices (cGMP) under 21 CFR Part 111, standard operating procedures (SOPs), and all safety protocols. The Packaging Operator plays a critical role in ensuring that finished products are properly sealed, labeled, and packaged for distribution.
Essential Duties and Responsibilities
Blister Carding Operations
• Set up, operate, adjust, and monitor blister carding machines to seal tablets and capsules into aluminum/PVC blister packs.
• Load bulk tablets/capsules into machine hoppers and load aluminum foil and PVC film rolls per machine specifications.
• Perform machine changeovers between product runs, including cleaning and line clearance procedures per SOPs.
• Monitor blister seal integrity, cavity fill accuracy, and reject mechanisms throughout production runs.
• Insert sealed blister packs into printed retail display cards per packaging specifications and artwork approvals.
Secondary Packaging
• Pack finished blister-carded products into cartons, cases, and shipper boxes per batch packaging orders.
• Apply case labels, lot numbers, expiration dates, and shipping labels accurately.
• Palletize finished cases per warehouse stacking and shipping requirements.
• Perform visual inspections of finished packaging for defects, misalignment, missing units, or labeling errors.
cGMP Compliance and Documentation
• Complete packaging batch records, line clearance forms, equipment logs, and label reconciliation documents accurately, legibly, and
contemporaneously in permanent ink per 21 CFR Part 111.
• Perform and document in-process quality checks including blister seal tests, weight checks, and visual inspections at required intervals.
• Verify that correct labels, cartons, and packaging materials are used for each product run (label reconciliation).
• Report any deviations, equipment malfunctions, or product quality concerns to the Production Manager and Quality Department
immediately.
Safety and Housekeeping
• Wear all required Personal Protective Equipment (PPE) including safety glasses, nitrile gloves, hairnet, and closed-toe safety shoes.
• Follow all lockout/tagout (LOTO) procedures when performing machine adjustments or clearing jams.
• Maintain a clean and organized work area in compliance with cGMP housekeeping standards.
• Follow all MKRS safety rules, including Hazard Communication (HazCom) and chemical handling procedures for cleaning agents and
sanitizers.
Qualifications
Required
• High school diploma or GED equivalent.
• Minimum 1 year of experience operating packaging equipment in a manufacturing environment, preferably pharmaceutical, nutraceutical, or
food production.
• Ability to read and follow written SOPs, batch records, and packaging specifications.
• Basic mechanical aptitude for machine setup, adjustment, and troubleshooting.
• Ability to perform basic math (counting, reconciliation, weight checks).
• Ability to stand for extended periods (8+ hours), lift up to 50 lbs., and perform repetitive motions.
• Willingness to work overtime and flexible schedules based on production needs.
• Must pass a pre-employment drug test and be subject to random, post-incident, and reasonable suspicion testing.
Preferred
• Experience operating blister packaging or carding machines.
• Previous experience in an FDA-regulated (cGMP) manufacturing environment.
• Familiarity with 21 CFR Part 111 documentation requirements.
• Being bilingual (English/Spanish) is a plus.
Equal Opportunity Employer
MKRS is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by federal, state, or local law.