Quality Associate

Bora Pharmaceuticals•Maple Grove, MN

7d•$52,000 - $67,000

About The Position

The Quality Associate issues cGMP documentation to operations in support of manufacturing and packaging operations. Reviews executed manufacturing/packaging documentation and dispositions batch release. Performs general quality assurance reviews/approvals. Performs document lifecycle administration functions.

Requirements

High School degree or equivalent and 3 years of experience in an FDA-regulated industry.
Alternatively, an associate degree in a technical field (e.g., Chemistry, Engineering, etc.) with 1 year of experience or a bachelor’s degree in a technical field (e.g., Chemistry, Engineering, etc.) with no experience may be accepted.
Industry experience must be in a cGMP production environment (preferably Pharmaceutical or Medical Device) with demonstrated proficiency in documentation generation and review.
Interpersonal, auditing, and proofreading skills required.
Ability to work independently or with a team; ability to perform detailed work.
Attention to detail required.

Nice To Haves

Experience in conducting and documenting investigations is a plus.
ASQ certification such as CQA, CQI, CQIA, etc. is a plus.

Responsibilities

Issues cGMP batch records and logbooks to operations in support of manufacturing and packaging operations. Ensures accuracy of documentation issued.
Perform review of executed manufacturing and packaging batch records to ensure documentation is complete and accurate. Works directly with operations personnel to resolve issues.
Performs final batch disposition.
Performs document lifecycle administration functions.
Ensures compliance and adherence to applicable department procedures. Provides suggestions for enhancements to procedures where necessary.
Assists Operations in situations requiring investigation. Provides suggestions for documentation resolution.
Participates in special projects assigned by QA Management.