JOB SUMMARY:
Leads and performs a variety of process duties according to batch record and Standard Operating Procedures (SOP’s) in the pharmaceutical manufacturing department, but not limited to, operating machines, and assisting in the packaging of products. The essential duties and responsibilities listed below are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.
ESSENTIAL DUTIES AND RESPONSIBILIITIES:
Follows all policies, procedures, and State, Federal and Local laws. Perform functions of Packaging Associate III, IV.
Troubleshoots downtime; competent in troubleshooting process issues. Communicates and coordinates changeovers and other equipment downtime issues with Packaging Associates.
Review batch record prior to production start. Monitors equipment throughout production ensuring proper operation.
Supervises other to ensure line is continually supplies with appropriate containers for filling and closures for sealing.
Ensures required documentation is entered into batch record accurately. Interfaces with Quality and Supervisors to inform of deviations or other line issues.
Fill in when Supervisor is absent. With Supervisor, coordinate each Packaging Associate(s) assignment during each shift.
Organize work of Packaging Associate(s) on assigned shifts. Answer questions, provide direction and training.
Prepare packaging line for production by confirming line clearance. Ensure line is setup per batch record.
Ensure correct labeling/packaging components are available. Effectively communicate with other departments. Communicate department issues & status updates.
Others duties as assigned.
EDUCATION AND/OR EXPERIENCE:
Experience in manufacturing processes and equipment procedures. 2 years’ experience in pharmaceutical, medical device, and/or food manufacturing. Familiarity with Food and Drug Administration (FDA), and other regulatory requirements. Understanding of SOP’s equipment and safety practices. Establishes and maintains cooperative working relationships with others. Responsible for full operation of Packaging machines. SME certified. Microsoft software experience is required.
QUALIFICATIONS AND/OR ABILITIES:
Excellent communication skills and the ability to recognize effective communication styles. Must manage shifting priorities in a dynamic operations setting. Strong problem-solving skills and the ability to executive corrective measures rapidly. Must have working knowledge of liquid fill processes including bottle fillers. Will recognize deviations from OSHA compliance on the operations floor.
PHYSICAL REQUIREMENTS/WORKING CONDITIONS:
The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Typical office environment requiring the use of typical office equipment (e.g. computers, phones, etc.). Continuously required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms, frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 40 lbs., safety glasses and forklift operation.
PAI is an Equal Opportunity Employer. PAI uses E-Verify.
EEO Employer / Veteran / Disabled