Manufacturing Associate II
On-siteYork, Pennsylvania, United States
Job Summary
Maintain aseptic technique certification and execute compounding, filtration, formulation, and fill activities for sterile injectable products in accordance with SOPs and GMP standards. Perform equipment preparation including CIP and SIP operations, conduct room sanitization, and accurately complete all production documentation and batch records. Identify and document operational deviations, participate in investigations, and assist engineering, warehouse, and facilities departments as needed. Revise Standard Operating Procedures, support new process validation with the tech transfer group, and train Manufacturing Associate I's. Maintain floor inventory and communicate schedule changes to the Supervisor.
Required Qualifications
- Associates or Bachelors Degree in Life Sciences/Liberal Arts field or equivalent experience preferred
- 2-5 years of professional manufacturing experience in an FDA Regulated Pharmaceutical facility
- 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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