Incumbent will be responsible for all aspects in solid dosage manufacturing of product to ensure compliance with cGMPs, SOPS, FDA, and DEA guidelines.
1. Operates production equipment required to manufacture solid dose pharmaceutical controlled substance products in compliance with cGMPs, SOPs, FDA and DEA guidelines.
2. Responsible for all manufacturing support functions such as preparation of equipment and manufacturing components to be used in support of/or manufacturing of the product.
3. Completes accurate and timely documentation to comply with FDA and GCP/GLP/GMP regulations.
4. Performs calculations, critical measurements and weights for production needs as stated in the Manufacturing Batch Record.
5. Uses computer systems to enter batch data, review Standards Operating Procedures (SOPs), and operate computerized manufacturing equipment.
6. Maintains current training in process area in order to support operational requirements. As required, develop the skills needed to perform duties in other areas to support schedule fluctuations.
7. Adheres to all regulatory guidelines including execution of supporting product documentation.
8. Adheres to all safety practices and participates in safety orientations. Provides input to Safety Team Leader and/or Committee.
9. Uses knowledge of pharmaceutical processes and associated production equipment to solve production and process problems.
10. Communicates with Technical Process Coordinator, Supervisor, and/or Senior Supervisor to ensure current requirements are met.
11. Performs other related assignments and duties as required and assigned.
1. Participates in Production team and Site communication meetings. Takes active role in supporting special departmental projects.
2. Demonstrates and fosters teamwork, positive can-do attitude and initiative. Respects the contributions of others. Demonstrates respect for diversity
Required Experience & Technical Requirements
- HS graduate with 5+ years cGMP pharmaceutical operations experience. Understanding of basic computer skills.
- Associates or Bachelor degree with 2+ years cGMP pharmaceutical operations experience.
2 - 5+ years cGMP pharmaceutical operations experience in solid-dosage manufactuing. Proficient and demonstrated experience in the Coating process areas/equipment operation in a solid-dosage manufacturing environment.Brief Description/Overview:
Purdue Pharma L.P. and its associated U.S. companies are known for pioneering research on the principal cause of human suffering: chronic pain. Headquartered in Stamford, Connecticut, it is one of the fastest-growing pharmaceutical companies in the world today. Purdue Pharma has led the battle against inadequate treatment of pain by developing long-acting pain-control medications that are prescribed by healthcare professionals around the world. As the sponsor of Partners Against Pain, the company provides community outreach and educational programs to encourage the therapeutic alliance of patients, their families, caregivers, and healthcare professionals.
Benefits: Purdue offers a wide range of competitive benefits to all full-time employees. Our benefit package includes a variety of benefit programs to provide for the health, welfare and financial security of our employees and their families.
We are an Equal Opportunity Employer committed to a diverse workforce, M/F/D/V. Corporate standards require pre-employment drug testing and background investigation.
If you are interested in a specific open position, you must apply online by visiting our website at www.purduepharma.com. No hard copy resumes will be considered.
Purdue Pharma L.P. - 2 years ago