QA Chemist at ANI Pharmaceuticals in Baudette, MN
This position is responsible for evaluating and maintaining the overall Quality Assurance standards throughout ANI Pharmaceuticals, through review of documentation and auditing of Quality systems. This position may also support coordinating and compiling Annual Product Reviews and Reports, authoring Product Quality Complaint Investigations, and performing Quality Systems Auditing Position
Responsibilities:
1. Perform review / disposition of manufactured raw materials, raw materials, packaging components and labeling. 2. Perform Finished Product record review / disposition and review of Stability Data. 3. Maintain the Hold/Reject system and provide improvements to the system. 4. Coordinate, assemble and maintain Annual Product Reviews. 5. Perform review of pre-approval / pre-printing labeling for ANI and contract packaged product. 6. Perform and author complaint investigations. 7. Perform Quality Systems Audits. 8. Perform other duties as assigned or requested. Position Requirements:
Bachelors degree in Chemistry, Engineering, Pharmacy or related sciences or applicable pharmaceutical experience. 5-10 years experience in pharmaceutical Quality Control and/or Quality Assurance. Must have the ability to manage multiple projects within a fast-paced environment. Must have the ability to organize and perform a wide variety of tasks efficiently with minimal supervision. Ability to partner with others to form a team to identify and correct problems. Ability to read and follow procedures. Ability to work independently. Must have great attention to detail. Complete, up to date working knowledge of cGMPs. Excellent interpersonal skills. Excellent organizational and follow through skills. Excellent written and verbal communication skills. Must be able to make quality decisions in a timely manner with minimal or no supervision. Must be able to work in a team environment. Must have a working knowledge of Quality Science as well as working knowledge of Quality Assurance Activities.
Salary Range:
$80K -- $100K
Minimum Qualification
Chemical EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
Responsibilities:
1. Perform review / disposition of manufactured raw materials, raw materials, packaging components and labeling. 2. Perform Finished Product record review / disposition and review of Stability Data. 3. Maintain the Hold/Reject system and provide improvements to the system. 4. Coordinate, assemble and maintain Annual Product Reviews. 5. Perform review of pre-approval / pre-printing labeling for ANI and contract packaged product. 6. Perform and author complaint investigations. 7. Perform Quality Systems Audits. 8. Perform other duties as assigned or requested. Position Requirements:
Bachelors degree in Chemistry, Engineering, Pharmacy or related sciences or applicable pharmaceutical experience. 5-10 years experience in pharmaceutical Quality Control and/or Quality Assurance. Must have the ability to manage multiple projects within a fast-paced environment. Must have the ability to organize and perform a wide variety of tasks efficiently with minimal supervision. Ability to partner with others to form a team to identify and correct problems. Ability to read and follow procedures. Ability to work independently. Must have great attention to detail. Complete, up to date working knowledge of cGMPs. Excellent interpersonal skills. Excellent organizational and follow through skills. Excellent written and verbal communication skills. Must be able to make quality decisions in a timely manner with minimal or no supervision. Must be able to work in a team environment. Must have a working knowledge of Quality Science as well as working knowledge of Quality Assurance Activities.
Salary Range:
$80K -- $100K
Minimum Qualification
Chemical EngineeringEstimated Salary: $20 to $28 per hour based on qualifications.
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