Production Associate I - 2nd Shift (B1)

Position Summary

Production Associate I is responsible for performing assembly, filling, labeling, inspection, and packaging of finished goods in compliance with current Good Manufacturing Practices (cGMP), FDA regulations, company procedures, and safety standards. This role supports daily production operations while ensuring quality, productivity, safety, and compliance requirements are consistently met.

Responsibilities and Essential Duties

• Maintain a clean, organized, and safe work environment in compliance with GMP, company policies, and established procedures including Lockout/Tagout (LOTO) and emergency stop (E-Stop) requirements.
• Follow all company safety rules, policies, and report unsafe conditions or behaviors immediately.
• Perform assembly, filling, bottling, capping, labeling, inspection, sorting, and packaging operations according to production schedules and work instructions.
• Conduct visual inspections of finished goods, labels, lot codes, and packaging components to ensure compliance with quality requirements.
• Stop work immediately, notify the Line Lead or Supervisor or Manager, and support initiation of a Notification of Event (NOE) in ETQ for any deviation from the process instruction, product defects, equipment issues, safety hazards, and quality deviations.
• Support line clearance activities and maintain proper housekeeping before, during, and after production runs.
• Handle raw materials, components, and finished goods according to established procedures.
• Maintain regular and reliable attendance and punctuality in accordance with the Employee Attendance Punctuality Policy.
• Be available to work overtime and occasional weekend shifts as production needs require.
• Observe personal hygiene and gowning requirements, and report to a supervisor any apparent illness, open lesion, or other health condition that may adversely affect product safety or quality, as required by 21 CFR 211.28.
• Follow and abide by the Company Employee Handbook at all times.
• Perform other related duties or projects as required.

Competency and Performance Expectations

• Proficiency requirements for this position are defined in the Production Competency Matrix.
• Qualification against the “Req.
• Production Associate I” column of that matrix is a condition of independent operation and consideration for progression to Production Associate II.
• Performance is reviewed periodically against the measures below; the full Above / At / Below Expectation criteria are maintained in the Production KPI Scorecard.

• Category
• Level I Expectation — Production Associate I
• Safety

Additional information

Follows all written safety requirements, GMP, SOPs, and safe work practices, including but not limited to LOTO, E-Stop, and machine guarding requirements, and does not bypass or shortcut safety procedures. Wears required PPE, maintains a safe and clean work area, and promptly reports injuries, near misses, unsafe conditions, and safety concerns.

Quality & Compliance

Performs assigned production activities in accordance with company policies, SOPs, Work Instructions, GMP requirements, and approved specifications. Maintains required documentation and traceability, and completes all required ETQ, company, and job-specific training.

Job Performance

Performs assigned production tasks accurately and demonstrates proficiency on assigned workstations and equipment. Develops the ability to perform assigned tasks independently while meeting established production standards.

Cost

Uses materials, components, equipment, and production time responsibly, and minimizes preventable waste, rework, errors, and material discrepancies.

Reliability & Conduct

Follows the Employee Handbook and company policies, including the Employee Attendance Punctuality Policy. Demonstrates punctuality, teamwork, communication, and professional conduct.

Level Progression - Production Associate I is a developmental position designed to build the production, quality, and safety skills required at the Production Associate II level.

Employees in this role will be evaluated for advancement to Production Associate II based on demonstrated competencies, including qualification under the Production Competency Matrix and the criteria in the Level I to Level II Promotion Readiness – Production Associate I form, as well as performance, attendance, adherence to safety standards, and business needs. Advancement decisions are made at the Company's discretion.

Advancement is not automatic or guaranteed, and time spent in this position does not alter the at-will nature of employment.

Technical Skills Required

• Ability to read, understand, and follow work instructions, SOPs, and production documentation.
• Basic understanding of GMP and workplace safety requirements.
• Ability to identify basic product defects and packaging inconsistencies.
• Basic math skills, including counting, verifying quantities, and completing production records.
• Ability to perform assigned production operations in accordance with approved work instructions.
• Ability to complete required production and quality records accurately.
• Ability to work cooperatively with Line Leads, Supervisors, and other team members.
• Ability to complete required training and demonstrate proficiency in assigned operations.
• Experience Required
• High school diploma or GED required.
• 0–2 years of manufacturing experience preferred.
• Experience in cosmetics, OTC, pharmaceutical, food, or dietary supplement industries is a plus.
• GMP manufacturing experience preferred.

Physical Requirements

• Ability to stand and walk for extended periods during the work shift.
• Frequent bending, squatting, kneeling, reaching, twisting, and climbing.
• Exposure to typical manufacturing environments including noise, moving equipment, airborne particles, cleaning agents, and temperature variations.
• Ability to distinguish colors, shades, and visual product characteristics for quality inspection.
• Must be able to read labels that could contain small fonts.
• Frequent performance of repetitive motions involving hands, wrists, fingers, and arms.
• Required to wear personal protective equipment (PPE), including safety glasses, gloves, hairnets, beard covers, and safety footwear.

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