Operations Associate - II

Job Summary

Plastikon Healthcare is looking for an Operations Associate II performing routine packaging activities for medical device and pharmaceutical products in accordance with approved procedures, current specifications, and applicable site requirements.

Working with limited supervision, this role completes packaging and documentation tasks accurately, performs required in-process checks, identifies and escalates issues, and helps maintain a safe, clean, and controlled manufacturing environment.

The Intermediate Packer also supports less-experienced packers by demonstrating established processes and reinforcing expectations for quality, safety, contamination control, and accurate recordkeeping.

Responsibilities

• Prepare packaging operations — Complete line clearance and verify that the area, equipment, materials, components, and documents are ready before starting work.
• Verify components and labels — Confirm identity, quantity, status, version, lot or batch information, and other required details against approved instructions before use.
• Package and seal product — Perform routine packaging, labeling, sealing, kitting, and related activities according to controlled procedures and approved specifications.
• Complete in-process checks — Perform required visual, dimensional, functional, seal, label, and other checks; record results at the time the work is performed.
• Inspect for defects — Identify damaged, missing, incorrect, contaminated, or otherwise nonconforming product, packaging, components, or labels and follow applicable hold and escalation procedures.
• Maintain traceability — Record and verify lot, batch, serial, device, or other traceability information, including serialization activities where applicable.
• Complete records — Accurately complete batch records, device history records, packaging records, checklists, logs, and electronic documentation in accordance with data integrity expectations.
• Handle materials — Receive, stage, move, count, protect, and return materials using approved methods that preserve identity, status, cleanliness, and condition.
• Check equipment — Perform assigned pre-use checks, verify equipment status, report abnormalities, and operate equipment only when trained and authorized.
• Reconcile materials — Count and reconcile product, components, labels, and packaging materials; promptly report discrepancies and do not independently adjust records outside approved procedures.
• Clean and maintain the area — Perform routine cleaning, line clearance, waste removal, and housekeeping activities required for the assigned area and product.
• Escalate issues — Stop or pause work when required, communicate deviations or unexpected conditions, and promptly notify the appropriate supervisor or quality contact.
• Support the team — Provide practical guidance to less-experienced packers while following training boundaries and referring questions or decisions to authorized personnel.
• Work safely — Follow safety rules, use required personal protective equipment, report hazards, and participate in required training and site activities.

Required Qualifications

• High school diploma or equivalent.
• Relevant experience in regulated manufacturing, packaging, warehouse, production operations, or a closely related environment.
• Ability to read, understand, and follow controlled procedures, work instructions, labels,
• specifications, and safety requirements.
• Ability to work independently on routine tasks while recognizing when guidance or escalation is required.
• Basic math, counting, and reconciliation skills with strong attention to detail.
• Ability to complete paper or electronic records accurately and in a timely manner.
• Ability to work effectively as part of a team and communicate issues clearly and respectfully.
• Ability to wear required PPE and perform the physical activities described below, with reasonable accommodation where applicable.

Preferred Qualifications

• Experience in medical device, pharmaceutical, biotechnology, or another GMP-regulated manufacturing environment.
• Experience with batch records, device history records, electronic production systems, label control, serialization, or lot traceability.
• Experience performing line clearance, in-process inspection, packaging equipment
• checks, cleaning, or material reconciliation.
• Familiarity with contamination control practices, controlled or cleanroom environments, and the use of visual inspection standards.
• Experience helping train, orient, or support coworkers on routine procedures.

#PKJOBS

Pay: From $20.50 per hour

Expected hours: 40.0 per week

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Life insurance
• Paid time off
• Professional development assistance
• Referral program
• Retirement plan
• Vision insurance

Work Location: In person

Salary : $21