Packaging Operator III

Position Summary

This position is an advanced-level packaging role responsible for supporting and executing packaging operations while maintaining compliance with all quality standards, cGMP requirements, and applicable Standard Operating Procedures (SOPs). The Packager III serves as a Subject Matter Expert (SME) for packaging processes and equipment, providing technical support, troubleshooting, and training to Operators I and II. This role operates independently and partners with Production Leads and Supervisors to ensure efficient, compliant, and high-quality packaging operations.

Essential Duties & Responsibilities

• Ensure personnel follow cGMP requirements and SOPs during packaging operations and maintain the suite is in a state of compliance.
• Perform and verify equipment and room setup activities, ensuring proper documentation is completed in applicable logbooks.
• Review completed batch records for accuracy, completeness, and compliance requirements.
• Verify all packaging materials are released and staged, and the quantities are verified by QA on the Work Instruction Sheet.
• Verify room status and packaging equipment used in the batch process are signed off by QA before starting batch.
• Accurately complete all required cGMP documentation and support documentation investigations when discrepancies occur.
• Operate, set up, adjust, and troubleshoot packaging equipment including labelers, heat sealers, tape machines, tablet counters, semi-automatic filling equipment, and related production equipment.
• Contact Production Lead or Supervisor/Management if there are any deviations from batch records or procedures.
• Ensure all approved Personal Protective Equipment (PPE) is utilized in accordance with policies and procedures.
• Comprehend and adhere to all Health and Safety regulations, policies, and procedures.
• Execute job duties with a high degree of quality, accuracy, efficiency, and customer service while meeting manufacturing schedules.
• Share technical knowledge and provide guidance to team members to improve operational efficiency and compliance.
• Train and mentor Operators I and II on equipment operation, safety procedures, and best practices.
• Perform additional duties assigned to support business objectives.

Safety Responsibilities

• Follow all company safety policies and procedures.
• Participate in required safety training.
• Report unsafe conditions, near misses, and incidents promptly.

Required Qualifications

Education: High School Diploma or equivalent

Experience: Minimum 3 years of experience in an FDA/cGMP regulated manufacturing or packaging environment. Demonstrated proficiency in packaging equipment setup, operations and troubleshooting.

Skills & Abilities:

• Facility Core, Production Core and Packager SOP requirements.
• Ability to work independently with minimal supervision.
• Strong troubleshooting and problem-solving skills.
• Ability to train and mentor team members.
• Ability to understand and follow detailed written instructions and procedures.
• Ability to perform basic mathematical calculations.
• Commitment to personal and team safety.
• Flexibility to support changing business needs in a fast-paced manufacturing environment.
• Effective verbal and written communication skills.
• Ability to analyze problems and recommend solutions.

Physical Requirements

• Standing/walking (on feet) 100%
• Lifting up to 25 lbs. 25%
• Stooping/bending over 25%
• Additional requirements include frequent standing, repetitive manual dexterity, reaching, walking, squatting, crawling, and safely lifting or team-lifting materials as necessary.

Work Environment & Culture

We offer a collaborative, employee-owned workplace where accountability, teamwork, and continuous improvement matter. Employees are encouraged to share ideas, grow their skills, and build long-term careers.

Compensation & Benefits

• Employee Ownership (ESOP): Company-funded retirement contribution of ~18% of pay, plus 401(k)
• Competitive pay with bonus opportunity
• Comprehensive benefits: Medical, Dental, Vision, Life, Disability, FSA, and Pet Insurance
• Generous paid time off, paid holidays, and parental leave
• Fitness reimbursement and tuition assistance
• Medical Insurance: Voluntary competitive medical insurance and prescription drug plan options.
• Dental Insurance: Choose from two voluntary dental plans.
• Vision Insurance: Voluntary vision insurance plan covering eye exams, frames, lenses, and contact lenses. Employee owners are responsible for 100% of the cost of this plan.
• Life Insurance with AD&D: Company-paid $50,000 life insurance policy with AD&D. Opportunity to purchase additional life and AD&D insurance for self, spouse, and/or dependent children (cost based on amount elected and age).
• Short- and Long-term Disability: Company-paid plans providing income replacement. Short-term disability: 70% income replacement up to $1,350 per week. Long-term disability: 60% income replacement up to $5,000 per month.
• Employee Assistance Program (EAP): Company-paid EAP providing up to six free counseling sessions for employee-owners and their families.
• Flexible Spending Account (FSA): Option to set aside pre-tax monies for medical reimbursement or dependent care. Maximum contributions determined by IRS and adjusted annually. Use-it-or-lose-it account.
• Pet Insurance: Options for furry friends offered through ASPCA. Employee-owners enroll and pay premiums directly to ASPCA.
• Paid Holidays & Paid Time Off (PTO): Includes Regular PTO, Personal PTO, and specified paid company holidays. Amount depends upon position and years of service.
• Employee Stock Ownership Plan (ESOP): All regular employees eligible first of month following 30 days of service. PBI-Gordon Companies contributes approximately 18% of total compensation annually with a six-year vesting schedule.
• 401(k) Retirement Savings Plan: Eligible first of month following 30 days of employment. Company match of 100% up to 3% deferral with a three-year vesting schedule.
• Fitness Reimbursement: Reimbursement up to $300 annually for gym/fitness memberships.
• William Everett & Mary Ellen Mealman Scholarship Fund: Children or grandchildren of employee-owners may apply; awarded based on financial need, academic achievement, and involvement in extracurricular/community activities.
• Tuition Reimbursement: After one full year of employment, eligible for reimbursement for bachelor's level coursework related to current or future job at PBI-Gordon Companies.
• Parental Leave: Company paid parental leave following birth, adoption, foster care, or surrogacy placement. Runs concurrently with FMLA leave, as applicable.

This response is AI-generated, for reference only.