Quality Assurance Compliance Associate

  Le Sueur, MN,  United States |  Full time

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Posting Date :  2023-03-09

Job Identification :  11141

Department  :  No Category

This role will report to the Quality Assurance Supervisor. The role is directly involved in ensuring that the production & distribution of products meets quality standards by performing a detailed review of technical documents, monitoring and trending quality data, verifying product quality, resolving deviations, and ensuring timely approval and release of products as per GMP standards. The role includes inspection of incoming labeling material to ensure compliance to approved specifications, development of labeling material and ensuring it meets quality standards, coaching/training operators and supervisors on proper documentation practices on cGMP requirements, in‐process documentation review and co‐investigation of deviations to ensure real‐time, high‐quality investigations and accurate and rapid corrective action impl ementation. This is a 1st shift position; 5:00 am to 1:30 pm; Monday through Friday.

Key Role Specific Requirements

  • Conducts incoming inspection of printed roll‐stock, labels, inserts, cartons, and packaging components using statistical sampling plans to ensure compliance with quality standards.
  • Performs label development tasks to ensure quality compliance for all new and revised label materials. 
  • Performs audits of external vendors to ensure compliance to quality standards.
  • Effectively works with label vendors to resolve issues and non‐conformance with labeling material and to identify areas for improvement.
  • Assesses potential impact of incidents and deviations on the quality and suitability of the product for sale. Includes conducting in‐process batch record review and all records associated with the batch and determining batch status, e.g. release, reject or product hold for further clarification or investigation.
  • Performs internal QA audits on manufacturing lines and finished products to ensure that they are compliant with corporate policies, practices, and procedures.
  • Prepares raw materials and finished product samples for submission to the Quality Control laboratory and monitors completion of testing and receipt of necessary documentation to facilitate Finished Product and Raw Material releases while ensuring quality compliance.
  • Investigates both individually and as a team member, deviations and OOS results to determine product impact, root cause, and corrective/preventative actions.
  • Monitors QA systems and advises/presents to management team on system performance; publishing metrics/reports regarding performance against set goals.
  • Conducts the annual inspection of retained samples and investigates any defects or discrepancies.
  • Provides support which includes but not limited to the preparation, review, and revision of master documents, specifications, and Standard Operating Procedures to ensure compliance.
  • Promotes and advocates quality achievement and performance improvement across the organization.
  • Participates as required in FDA, HPRA, and customer audits and ensures corrective actions are completed within specifications or SOPs.
  • Ensures ongoing compliance with local, national, and international standards and legislation.

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Competencies Required for the Role
Please include no more than 5 competencies most applicable to this role from the list provided. Include the definitions provided as well.

INTEGRITY/PERSONAL CREDIBILITY – Demonstrated ability and concern that one be perceived as
responsible, reliable, and trustworthy

FOSTERING COLLABORATION/TEAMWORK‐ is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.

ANALYTICAL THINKING/PROBLEM SOLVING ‐ is the ability to identify the information needed to clarify a
situation, seek that information from various sources and then tackle a problem by using a logical,
systematic, sequential approach. Ability to identify and separate the key components of problems and
situations. Ability to interpret information from a range of sources to spot patterns and trends in
information and to deduce cause and effect from this.

THOROUGHNESS/DETAIL ORIENTED Ensuring that one’s own and others’ work ad information are
complete and accurate; carefully preparing for meetings and presentations following up with others to
ensure that agreements and commitments have been fulfilled.

THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are
complete and accurate; carefully preparing for meetings and presentations following up with others to
ensure that agreements and commitments have been fulfilled.


Other Requirements:

  • 2‐3 years’ relevant experience in a regulated pharmaceutical industry including quality assurance &/or quality control.
  • BSc degree or quality assurance courses or quality training.
  • Knowledge of pharmaceutical or food quality assurance methodologies, cGMP, and quality systems.
  • High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize, work in team environment and individually, and take initiative.
  • Strong problem identification and problem resolution skills.
  • High level of proficiency with Microsoft Office.
  • Physical ability to tip and maneuver 100‐pound roll stock rolls, and bend, squat, and lift 25 pounds.
  • Excellent written and verbal communication skills for liaising and communicating with internal departments and external vendors.
  • Strong work ethic and positive team attitude
  • Experience and knowledge with Continuous Improvement programs.

About Bimeda
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science‐driven solutions to optimize the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation program sees eight state‐of‐the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever‐evolving needs of the animal health industry.
Bimeda’s eleven manufacturing facilities across eight countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water‐soluble powders, pastes and non‐sterile liquids.
Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda‐branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.

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About Us

Bimeda is a leading global manufacturer,  marketer and distributor of animal health products and veterinary pharmaceuticals.  Through ongoing expansion and strategic acquisition,  Bimeda has established markets in more than seventy countries worldwide and has R&D,  manufacturing and distribution capabilities across Europe,  North America,  South America,  Africa,  Asia and Australasia.






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