Almac Group is currently seeking a 2nd Shift Production Line Lead Operator for our Audubon, PA location. The Production Line Lead will perform assigned functions at Almac Pharma Services relevant to the packaging area ensuring that quality is maintained in products for the safety, well-being, and protection of the patient. The Production Line Lead is responsible for the production personnel, material and documentation within an assigned production room to ensure the quality and through put are maximized and that orders are processed in a safe, cGMP compliant and timely manner.
Responsibilities include but are not limited to:
- Perform leadership role while in packaging rooms, including training the production team on the packaging operation and monitoring the performance of the staff to ensure the finished product is being packaged correctly. Complete all required associated documentation per Almac SOPs ensuring accurate information is recorded.
- Execute batch documents including issuance, reconciliation, recording of finished product, and required inspections using the inventory system and manually recording required details in the batch document according to appropriate Almac Standard Operating Procedures (SOP’s) and current Good Manufacturing Practices (cGMP’s).Ensure no non-validated equipment is utilized for production operations.
- Perform and ensure that thorough, routine cleaning of equipment and packaging rooms is performed according to appropriate Almac SOP’s) and current Good Manufacturing Practices (cGMP’s).
- Organize layout of production operations according to batch documentation to ensure efficient and secure processing relative to the written requirements. Communicate to Production Mechanic regarding any machine inefficiencies.
- Communicate to Production Coordinators about room activity and progress/inefficiencies.
- Coordinate with Maintenance staff to ensure efficient equipment set-up and efficient running of equipment during an operation.
- Escalate issues to Maintenance staff to minimize downtime during an operation.
- Develop expertise in allocated processing areas to ensure process compliance. Actively communicate this knowledge to co-workers and Supervisory staff.
- Monitor performance on a periodic basis during the shift, record data on batch progression, machine efficiency and downtime to enable accurate OEE analysis.
- Undertake processing operations in compliance with cGMP, batch documentation and SOPs, including the performance of process supervisory check within batch records.
- Operate equipment to produce the required batch in compliance with GMP, batch documentation and SOPs.
- Organize and manage team members to ensure compliance with GMP, batch documentation and SOPs.
- Perform additional line clearance and cleaning verification checks where required to assist Supervisory staff.
- Ensure all set up checks and challenges are performed as required during the production operation.
- Ensure all team members are trained and competent in the tasks they are performing.
- Respond to employees’ queries regarding compliance and quality concerns.
- Report any compliance and quality concerns, breaches of procedure or examples of substandard quality to the Production Coordinator or Supervisor.
- Complete all documentation in a tidy and accurate manner. This includes Work Orders, Validation Protocols, Room and equipment Log Books, In Process Check sheets (IPCs) and Acceptable Quality Level sheets (AQLs).
- Assist with validations.
Qualifications:
Required Experience / Education:
- High School Diploma or GED
- Minimum one year Machine/Mechanical or related experience
- Minimum two years Operations or related experience
- Processing or mechanical equipment
Preferred Experience / Education:
- Mechanical/Electrical degree or training
- Pharmaceutical or similar GMP environment
- Pharmaceutical processing equipment in GMP environment
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 as well as one day for Annual Diversity Day
- 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 over 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.
Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.
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