Quality Assurance Associate

Bimeda•Ottawa Township, MN

23h

About The Position

Reporting to the QA Supervisor, the QA Associate will work within an established culture of Quality Assurance and continuous improvement in all GMP areas. The QA Associate will be directly involved in all areas of quality assurance, including change control, facility compliance, product and material release, review of technical documents, deviation resolution, and ensuring GMP standards are met. The role includes coaching/training operators and supervisors on proper documentation practices and on cGMP requirements to ensure compliance during manufacturing.

Requirements

Minimum 1+ years of direct work experience with pharmaceutical or food manufacturing Quality Assurance systems, regulations, guidelines, and associated standards
Training and knowledge of cGMP regulations
Extremely detail-oriented and analytical thinker with strong problem-solving ability
Able to develop, review, and maintain metrics and quality audits
Able to interface directly with cross-functional teams
Proficiency in use of computer applications and programs such as Microsoft Office, Excel and PowerPoint
High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize, and work in team environment, take initiative
Highly motivated and self-directed, capable of multi-tasking, and able to work with minimal supervision
Strong work ethic and positive team attitude
Bachelor’s degree in a related Science or equivalent experience.

Responsibilities

Assess potential impact of incidents and processing deviations on the quality and suitability of the product for sale. Includes conducting batch record review and determining batch status, e.g., release, reject or product hold for further clarification or investigation.
Conduct incoming inspection of printed roll-stock, labels, inserts, and cartons using statistical sampling plans to determine the acceptability of printed labelling.
Interact with label vendors if problems exist.
Investigate both individually and as a team member, product complaints, deviations, and OOS results to determine product impact, root cause and corrective/preventative actions.
Perform internal quality audits that are compliant with corporate policies, practices, and procedures.
Promote and advocate quality achievement and performance improvement across the organization.
Ensure ongoing compliance with local, national, and international standards and legislation.
Participating in HPRA, FDA, & customer audits/inspections and ensuring corrective actions are completed as required.
Perform initial inspection of the packaging lines to ensure compliance to company Standard Operating Procedures (SOP).
Assist with resolution of compliance issues related to manufacturing lines to ensure compliance with company Standard Operating Procedures (SOP).
Write, review, and revise Standard Operating Procedures (SOP) and any related forms for specific job-related activities.
Support Continuous Improvement program throughout the company.
Review batch documentation for cGMP compliance and work with production personnel to resolve discrepancies.
Perform QA release of finished product for acceptable materials, to include counting and tagging outgoing pallets of finished products. Establish files for all batch documentation.
Prepare raw materials and finished product samples for submission to the Quality Control laboratory and monitor completion of testing and receipt of necessary documentation to facilitate Finished Product and Raw Material releases. Review completed analysis for conformation to specifications.
Keep Management informed of discrepancies, deviations, investigations, and unusual trends as they occur and assist in identifying root cause and countermeasures to prevent recurrence.