Production Investigator (Packaging Operations)

Almac Group is currently seeking a Production Specialist (Packaging Operations) for our Audubon, PA location. 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. *40 hours or beyond if needed Shift: 8am-5pm or beyond if needed Responsibilities include but are not limited to: 1. Ensure investigations, corrections and CAPAs are generated and closed out in a timely manner 2. Generate Change Requests & Production Protocols when required to support the production schedule. 3. Manage, conduct/coordinate, track, and follow-up of activities related to trend CAPA's 4. Coordinate the review of trend CAPA's to determine their effectiveness 5. Support Production Batch Record Issuance 6. OSM, Material Allocation and Label Generation 7. Participate in development projects where required 8. Responsible for support of new business and process improvement projects. 9. 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. 10. Perform Serialization activities if required 11. Support the compiling of any Standard Operating Procedures, Cleaning Instruction Records or other documents. 12. Ensure compilation of all documentation (Batch Records, Validation Protocols, etc.) is accurate. Qualifications: Required Education: HS Diploma/GED Preferred Education: Bachelor's degree in life science or related field Required Work Experience: 1. 3 years in Pharmaceutical or similar GMP environment 2. Experience compiling technical documentation, e.g. SOP's, Batch Records, Validation protocols, etc. 3. Working knowledge of pharmaceutical packaging & manufacturing processes, including cGMPs 4. 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 5. Experienced authoring/leading investigations in a Pharmaceutical Manufacturing or Packaging environment Preferred experience: 6. 5 years in Pharmaceutical or similar GMP environment 7. 3 years' experience with the generation, execution and review of quality documents in a commercial pharmaceutical packaging facility. 8. Six Sigma Green or Black Belt Certified Preferred Knowledge 9. Root Cause Analysis 10. Investigations/Technical Writing 11. Process Packaging 12. Lean Manufacturing 13. Experience with pharmaceutical packaging equipment including but not limited to bottle filling, blister card packaging, vial & ampoule labelling, kit assembly and pouching operations. 14. Green Belt or Black Belt Certification What can Almac Group offer you? 1. Medical, Vision & Dental benefits from the 1st of the month following start date 2. 20 days PTO per year, accrued monthly following start date 3. 12 holidays per year 4. Company paid Long and Short-term disability along with Life Insurance 5. 401k company contribution 6. Professional development programs/ continuous learning opportunities What can Almac Group offer you? 1. Medical, Vision & Dental benefits f om the 1st of the month following start date 2. 20 days PTO per year, accrued monthly following start date 3. 12 holidays per year 4. Company paid Long and Short-term disability along with Life Insurance 5. 401k company contribution 6. Professional development programs/ continuous learning opportunities Want to see our latest job opportunities? Follow us on LinkedIn Almac is an exceptional, award winning, drug development solutions provider at the forefront of the pharmaceutical industry. We are a privately owned organization that has organically grown over 50 years now employing 7,500 highly skilled personnel worldwide. Our US Headquarters is located at Souderton, PA with additional operations scattered around the US and Europe. 'Partnering to Advance Human Health' is more than just a tagline - it is our way of life. Embracing diversity is at the heart of enhancing Almac Group's unique culture and reflects our fundamental belief that all people deserve equality, inclusivity and the opportunity for advancement. We are committed to cultivating a welcoming, supportive, and inclusive environment for all. Together, we will build on the strength in our diversity and deliver exceptional solutions to advance human health globally. RECRUITMENT AGENCIES PLEASE NOTE: Almac will only accept applications from agencies/business partners that have been invited to work on this role through our portal. Candidate Resumes/CV's not submitted through our portal or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation. Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions. EEO is the Law EEO is the Law GINA Supplement Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [email protected] to request assistance.