Manufacturing Associate III
On-siteYork, Pennsylvania, United States
Job Summary
Execute aseptic and non-aseptic filling, compounding, filtration, and formulation activities while maintaining certification for gowning and adhering to GMP/ISO standards. Perform equipment preparation, cleaning, and sanitization operations, including CIP and SIP, and accurately complete production documentation and batch records. Lead teams to manage floor activities, initiate deviations, and assist in investigations with cross-functional departments such as engineering, QA, and validation. Revise Standard Operating Procedures and support the formulation and validation of new processes in partnership with tech transfer. Maintain floor inventory and communicate schedule changes as needed. Willing to work extended shifts and a variable schedule.
Required Qualifications
- Bachelor's Degree in a Life Sciences or Liberal Arts field, or equivalent experience
- 5-7 years of professional manufacturing experience in an aseptic, FDA-regulated pharmaceutical facility
- Ability to manage floor activities in the absence of the Supervisor
- Experience in reviewing and creating controlled documents
- Experience with sterile injectable drug products and well versed in aseptic technique
- Familiarity with formulation, filling, primary packaging, and aseptic processing
- Willingness to work extended shifts and a variable schedule when required
- Skilled in MS Office/Excel tools
- Excellent communication skills, verbal and written
- Self-motivatedl with the ability to complete multiple floor activities in an effective and compliant manner
- Strong attention to detail, organizational skills, and commitment to quality
- Proven ability to plan and prioritize complex activities
- Strong analytical skills and mechanical aptitude to identify risks and prepare balanced decisions
- Positive attitude and strong interpersonal skills
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