Supplement to the team.
Top 3 Must Have Skill Sets:
• Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
• Experience in and knowledge of GMP/GCP operations or similarly regulated industry
• Highly effective verbal and written communication skills, strong interpersonal skills
• Great attention to detail and high degree of accuracy in task execution and GMP documentation
• Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues.
• Strong organizational skills, including ability to follow assignments through to completion.
Day to Day Responsibilities:
• Provide daily guidance and support to manufacturing staff regarding compliance with Standard Operating Procedures and Work Instructions.
• Ensure regular presence on the packaging area to provide oversight to GMP operations and quality systems.
• Act as a first point of contact in case of production staff inquiries (quality related) during operations.
• Review and approve batch record documentation, assist in sampling and inspections as required and other GMP documentation in support of daily operations.
• Own, review, and approve controlled documents, including Standard Operating Procedures (SOPs), Work Instructions and Forms.
• Review and approve minor deviations.
• Adhering to safety rules and maintaining a safe work environment for both yourself and others by supporting Environmental Health and Safety corporate and site goals.
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