Job Description

Key Responsibilities:

• Oversee the organization of records and coordinate activities related to Production and Quality Assurance. This includes reviewing and authorizing batch records and work orders for distribution.
• Assist in manufacturing and packaging processes by ensuring batch-related documentation is prepared and accurate, supporting the efficient production of finished goods while ensuring adherence to cGMP and SOPs.
• Evaluate documents related to manufacturing and packaging to confirm accuracy and compliance with cGMP standards and SOPs.
• Systematically organize and catalog batch-related documents, ensuring they are readily accessible for future reference.
• Maintain and manage records and documents in an organized manner to support smooth packaging and manufacturing operations.
• Review batch records and work orders, ensuring quantity reconciliation is performed in compliance with QA requirements.
• Offer support for investigations when necessary, addressing issues within manufacturing or packaging processes.
• Collect and analyze data to identify patterns and implement improvements.
• Perform other duties as required.

Qualifications and Experience:

• High School diploma or equivalent required.
• At least two years of experience working in a cGMP-regulated environment.
• Strong reading comprehension and the ability to understand technical production documentation.
• Proficiency in mathematical skills, as verifying calculations is an essential part of the role.
• Computer literacy is required, including familiarity with cGMP standards in a pharmaceutical context.
• Strong organizational skills, particularly in managing and cataloging documents.

offers competitive compensation and a full benefits package, which includes health and dental insurance, as well as a 401(k) plan. Please submit your resume for immediate consideration.

The salary stated is an estimated base compensation for this position at the time of posting and may be adjusted in the future. Several factors may influence the final salary, as permitted by law.

Equal opportunity employer and prohibits discrimination based on race, color, religion, national origin, ancestry, citizenship status, age, gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military or veteran status, physical or mental disabilities, genetic information, or any other characteristic protected by applicable laws.

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