Manufacturing Associate IV

About This Role:
As a Manufacturing Associate IV, you will be an integral part of the Aseptic Operations team, operating within a cGMP environment to ensure the highest standards of product quality and safety. Your primary focus will be on supporting aseptic processing activities conducted under a Bio safety Cabinet (BSC) in a Grade C environment. This role emphasizes precision, accountability, and compliance, requiring you to perform and document daily manufacturing operations with rigor and attention to detail. Your work will directly contribute to maintaining a controlled, compliant, and inspection-ready manufacturing environment, ensuring that our products meet stringent quality standards critical to patient safety.

This position offers the opportunity to demonstrate your expertise in aseptic operations while supporting weekend operations on a rotational basis.

What You'll Do:

• Execute aseptic manufacturing operations under Biosafety Cabinets in a Grade C environment, following approved PRCDs and Work Instructions.
• Perform material handling, preparation, and aseptic manipulations in alignment with contamination control strategies.
• Adhere to gowning and decontamination requirements, ensuring seamless transitions between Grade C and Grade A environments.
• Apply approved cleaning and disinfection practices to materials and equipment before introducing them into controlled areas.
• Monitor operations against batch records, promptly reporting any deviations or abnormalities.
• Ensure accurate, complete, and timely GMP documentation in compliance with Good Documentation Practices (GDP).
• Escalate issues or non-conformances following site procedures.
• Contribute to maintaining a controlled, compliant, and inspection-ready manufacturing environment.

• Minimum of 5 years experience in a cGMP manufacturing environment.
• Strong knowledge of aseptic techniques and contamination control principles.
• Proven ability to follow procedures, work instructions, and protocols accurately.
• Strong attention to detail in both execution and documentation.
• Ability to operate effectively in a structured, regulated manufacturing environment.
• Working knowledge (or ability to quickly learn) of manufacturing and quality systems such as DeltaV, Syncade, LIMS, and TrackWise.

• Demonstrated ability to perform precise aseptic operations within a Biosafety Cabinet (BSC).
• Experience with enhanced gowning requirements and aseptic behaviors.
• Familiarity with decontamination techniques, such as IPA disinfection and controlled material transfer.