QA Manager


Job ID 18-00226

Industry Pharma

Job Type Permanent

Location Decatur, IL

Description

Summary:
Manages, implements and coordinates quality assurance program to prevent or eliminate defects in new or existing products by performing the following duties.
 

Essential Functions:
Evaluate personnel requirements of the quality assurance operations department.
Review/Release production batch records and release products.
Review/close out any aborted batch records.
Maintain Quality Metrix for batch record review.
Respond to request from 3rd party customers.
Reject any batch that fails to meet specifications.
Provide data from batch record review for analysis during annual product reviews.
Provide responses to audit observations and deficiencies.
Manage QA auditors in process audits.
Manage QA Batch Record Reviewers
Maintain/update QA Operations Training Plans.
Update Quality Operation departmental training curriculums.
Review/update QA departmental SOPS as applicable.



Qualifications

Qualifications: 
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed are representative of the knowledge, skill, and/or ability required.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 
 

Education and Experience:
Bachelor's Degree (BS or BA) in a science related filed (i.e. math, chemistry, biology); five years related managerial or supervisor experience in the pharmaceutical industry.
 

Mental requirements include:
Ability to apply deductive reasoning and understand complicated issues.
Ability to receive instructions and follow work rules and company policies.
Ability to follow safety and security practices.
Ability to meet deadlines and effectively deal with office stress.
Ability to accurately communicate ideas, facts and technical information.
Maintain confidentiality of certain information.
 

Candidate Details:
5+ to 7 years' experience
Seniority Level - Mid-Senior
Management Experience Required - No
Minimum Education - Bachelor's Degree
Willingness to Travel – Occasionally
 

Minimum requirements for role:
At least 3 years in current role 
Supervisor / manager experience 
Aseptic experience
Sterile experience 
Pharma background
No candidates from API or device companies