Manufacturing Operator - 1st Shift - Solids

Job Summary:

Performs functions relating to the processing and packaging of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity, and timing. Learns to apply skills and knowledge to recognize issues and to increase efficiency, throughput, and quality. Learns, understands, and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, may participate in the debrief to understand the reasons why and what needs to be corrected moving forward. Assists in troubleshooting process issues. Responsible for the safe and efficient execution of job duties. Perform other duties as assigned.

Job Responsibilities:

• Comply with all workplace standards and safety procedures, including Lockout Tagout, Current Good Manufacturing Practices (cGMPs), Occupational Safety and Health Administration requirements (OSHA), Standard Operating Procedures (SOPs), and Company Guidelines.
• Perform the daily setup and routine operation of the packaging line, including but not limited to: bottle in-feed, unscrambler, filler, bottle capper, torquer, labeler, vision systems, weighing systems, bar coding systems, sealers, disassembly/assembly, cleaning, resolving equipment stoppages and jams, and all material handling as trained.
• Inspect packaging components, in-process items, and packaged drug products to assure compliance to specifications, identify any non-conforming item and initiate appropriate actions.
• Palletize both finished and unfinished products and operate non-motorized material handling equipment.
• Complete, maintain, and update production documentation (both electronic and paper) to perform material movements, material take-outs and yield determinations by following SOPs and utilizing systems as required such as Systems/Applications/Products (SAP), Manufacturing Execution Systems (MES), Electronic Batch Records (EBRs), etc.
• Take ownership of training and learning to develop high performance competencies such as technical skills, communication skills, and skills to build a team-oriented, customer focused, and collaborative culture.
• Meet the production schedules outlined by line lead and/or Supervision. Review and approve work output for team members by using validated methods.
• Perform preventive maintenance tasks as needed and trained.
• Manage area cleaning requirements including facility, equipment, and Operational Excellence initiatives.

Qualifications:

• High School Diploma or GED required.
• Good written and verbal communication skills in English.
• Good PC Skills, including use of e-mail, attaching documents to e-mail. Previous experience using electronic databases and on-line system applications.
• Demonstrated ability to work safely in a production environment required.
• Demonstrated ability to read/interpret/follow instructions regarding workplace documentation, such as SOP’s, Operator Manuals, Work Instructions, etc.
• Demonstrated technical ability as measured by good troubleshooting skills.
• Must be able to demonstrate a good mathematical aptitude in addition, subtraction, multiplication, division, & metric system.
• Experience in a government regulated, Good Manufacturing Practices (GMP) or standard operating procedures (SOP) environment preferred.
• Must be willing to work overtime as required, based on production demands.