Compounder Lead
Job Description
This position is responsible for ensuring sterile product is produced in accordance with applicable standards (e.g., cGMP, SOPs) by weighing chemicals, compounding, testing and releasing the solution for use in production. In addition, this role is also responsible for planning and scheduling shift activities with the manager.
Key Responsibilities:
- Produce and manufacture sterile and bulk pharmaceutical products in accordance with applicable standards and procedures (cGMP, SOPs, etc.).
- Compound Media solution for revalidation of filling process.
- Accurately and completely document activities in MBR's, checklists, and all other compounding documents.
- Set up equipment and perform CIP (clean in place), SIP (steam in place), mixing, filter integrity test, bulk sterilization, and sterile transfers according to SOPs, MBRs, and associated documents for assigned work area.
- Strictly adhere to Current Good Manufacturing Practices (cGMP), Current Good Documentation Practices (cGDP), and Standard Operating Procedures (SOP's) and report all discrepancies immediately.
- Accurately weigh chemicals for production, domestic, international and R&D uses.
- Prepare, clean, and sterilize equipment used for manufacturing of bulk product.
- Execute Preventive Maintenance.
- Perform Safety and Quality Audits.
- Perform aseptic powder additions and slurry transfers to sterile bulk pharmaceutical products.
- Prepare and sterilize ancillary equipment with a steam autoclave.
- Complete required documentation in accordance with cGMP and cGDP.
- Troubleshoot problems with equipment/processes, alerting maintenance or supervisors as needed.
- Perform pH titrations: Use computerized systems in manufacturing and documenting activities
- Collaborate with coworkers to meet business objectives and enhance team capability.
- Plan work activities in accordance with production schedule, and shifting priorities.
- Verify production schedule to determine and adjust activities according to production priorities.
- Share knowledge and experience with coworkers to develop team's overall capability.
- Collaborate with Quality Assurance on product quality issues and compliance activities.
- Collaborate with Maintenance to resolve problems with equipment.
- Exchange accurate and complete information regarding production with supervisor, other shifts, and other departments.
- Communicate and work with Production to ensure efficient CIP/SIP and flush flow of materials and products to/from warehouse.
- Keep work areas clean and free of hazards or dangerous conditions Perform duties in accordance with Health, Safety, and Environmental standards.
- Participate in site safety programs, identify and report safety hazards or unsafe behavior.
Key Requirements/Minimum Qualifications:
- High School Diploma or equivalent
- The ability to fluently read, write, understand and communicate in English
- 3 Years of Relevant Experience
- Work hours: 2nd Shift - Tuesday - Saturday, 3pm - 11:30pm
- Travel Requirements: 0%
- Relocation assistance: No
- Sponsorship available: No
Preferred Experience:
- Demonstrated Leadership
- Assertive
- Communicates effectively
- Manage Time effectively
- Collaborates well in team atmosphere
- Proficient in excel
Alcon is an Equal Opportunity Employer and participates in E-Verify. Alcon takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. Alcon is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to [email protected] and let us know the nature of your request and your contact information.
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Date Posted
04/29/2023
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8
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