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Form of workJob Description
Our partner is a large manufacturer in the biotech industry and they are seeking a Senior Manufacturing Associate for their site in Thousand Oaks, CA!
Pay: $31/hr - 34/hr
Responsibilities:
• Change control ownership, ensuring records are comprehensive and compliant per GMP regulatory procedures.
• Demonstrate strong project management skills, with a preference for candidates with prior project experience.
• Ensure timely closure of change control records in alignment with procedural guidance and disposition timelines.
• Act as the representative for for manufacturing, serving as the receiving site for incoming technology transfers and new product introductions into building.
• Identify opportunities for improvement within the organization and proactively work to build consensus for implementing these opportunities.
• Effectively communicate verbally and in writing with staff and leadership in a concise manner.
• Present records and business processes to various audiences, including auditors and inspectors.
• Actively participate in or lead continuous improvement transformation activities.
• Follow safety regulations throughout all step of the manufacturing processes.
Requirements:
• Holds a Master's Degree, in life sciences industry or engineering.
• Proficiency in utilizing PAS X Werum software for electronic batch records.
• Technical knowledge of Drug Product (DP) manufacturing operations, including but not limited to buffer batching, DP formulation, DP filling, and inspection.
• Previous experience in leading change controls using Trackwise.
• Effective and collaborative scientific and technical interactions with partner organizations such as Process Development, Process Engineering, Supply Chain, Quality Control, and Regulatory.
• Proven ability to work seamlessly within a team environment.
• Demonstrated skill in technical writing.
Astrix provides scientists to a broad spectrum of scientific based industries including: Chemical, Biotech, Pharmaceutical, Cosmetics, Food Science, Flavors and Fragrances, Biomedical, Consumer Products, Environmental, Medical device, Petrochemical and Clinical Research.
