Production Specialist 1

About the role

The Production Specialist supports production activities which contribute to the on time execution of the production schedule on a daily basis. Activities include but are not limited to performing deviation investigations as they arise, support batch record issuance, and maintain quality management systems for production related tasks (capas, change requests, and other documentation) while maintaining the key quality indicators. They will also assist in the successful introduction of new products, equipment and associated processes and procedures, including standard operating procedures, cleaning instruction records and serialization validations. The production specialist will also review production processes to identify opportunities for potential efficiency and safety improvements.

Responsibilities

• Ensure investigations, corrections and CAPAs are generated and closed out in a timely manner
• Generate Change Requests & Production Protocols when required to support the production schedule
• Manage, conduct/coordinate, track, and follow-up of activities related to trend CAPA's
• Coordinate the review of trend CAPA's to determine their effectiveness
• Support Production Batch Record Issuance
• OSM, Material Allocation and Label Generation
• Participate in development projects where required
• Responsible for support of new business and process improvement projects
• Support the delivery of an effective and efficient qualification and validation in accordance with Almac Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMP), and customer specifications
• Perform Serialization activities if required
• Support the compiling of any Standard Operating Procedures, Cleaning Instruction Records or other documents
• Ensure compilation of all documentation (Batch Records, Validation Protocols, etc.) is accurate

Required Education

• HS Diploma/GED

Preferred Education

• Bachelor's degree in life science or related field

Required Work Experience

• 3 years in Pharmaceutical or similar GMP environment
• Experience compiling technical documentation, e.g. SOP's, Batch Records, Validation protocols, etc.
• Working knowledge of pharmaceutical packaging & manufacturing processes, including cGMPs
• Understanding of process control systems and their functional operation on automated production lines
• Proven ability to work effectively on own initiative and within the boundaries of GMP and SOP's
• Experienced authoring/leading investigations in a Pharmaceutical Manufacturing or Packaging environment

Preferred Experience

• 5 years in Pharmaceutical or similar GMP environment
• 3 years' experience with the generation, execution and review of quality documents in a commercial pharmaceutical packaging facility
• Six Sigma Green or Black Belt Certified

Preferred Knowledge & Skills

• Root Cause Analysis
• Investigations/Technical Writing
• Process Packaging
• Lean Manufacturing
• Experience with pharmaceutical packaging equipment including but not limited to bottle filling, blister card packaging, vial & ampoule labelling, kit assembly and pouching operations
• Green Belt or Black Belt Certification

Benefits

• Medical, Vision & Dental benefits from the 1st of the month following start date
• 20 days PTO per year, accrued monthly following start date
• 12 holidays per year
• Company paid Long and Short-term disability along with Life Insurance
• 401k company contribution
• Professional development programs/ continuous learning opportunities

Schedule

40 hours or beyond if needed. Shift: 8am-5pm or beyond if needed.