Production Specialist 1

Almac Group; Souderton (Montgomery County); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical, Vision & Dental benefits

PTO 20 days per year

12 holidays per year

Long and Short-term disability

401k company contribution

Professional development programs

Job summary

Almac Group is seeking a Production Specialist (Packaging Operations) for our Audubon, PA location to support on-time production and maintain quality systems. You will handle deviation investigations, batch record issuance, CAPA activity, change requests and SOP maintenance to ensure compliant packaging processes.

The role emphasizes collaboration on projects, validation activities, and continuous improvement of packaging lines, with a 40-hour week and potential extended shifts as needed.

Qualifications

• 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 (SOPs, Batch Records, Validation protocols)
• Working knowledge of pharmaceutical packaging & manufacturing processes, including cGMPs
• Investigations/Technical Writing
• Lean Manufacturing
• Six Sigma Green or Black Belt Certified
• Experience with packaging equipment such as bottle filling, blister card packaging, labeling, kit assembly

Responsibilities

• Ensure investigations, corrections and CAPAs are generated and closed out in a timely manner
• Generate Change Requests & Production Protocols 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 as required
• Support the delivery of qualification and validation in line with SOPs and cGMP
• Support compiling of Standard Operating Procedures and Cleaning Instruction Records
• Ensure compilation of all documentation (Batch Records, Validation Protocols, etc.) is accurate

Skills

GMP experience

Investigations

Documentation

SOPs

Batch Records

Lean Manufacturing

Six Sigma Green/Black Belt

Process Packaging

Validation protocols

Education

HS Diploma/GED

Bachelor’s degree in life science or related field

Job description

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 and 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:

• 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.
• 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.

Qualifications:

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
• 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

What can Almac Group offer you?

• 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

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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.

Almac Group, Inc. is an Equal Opportunity Employer - Minorities/Women/Protected Veterans/Disabled - Proudly embracing diversity in all of its expressions.

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Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at [e-mail] to request assistance.