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Quality Assurance Compliance Associate

  Irwindale, CA,  United States |  Full time

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Posting Date :  2022-05-26

Job Identification :  11013

Department  :  Quality Assurance

Reporting to the Compliance Manager, the Quality Assurance Compliance Associate 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 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 implementation.

Key Role Specific Requirements

 
  • 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 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.
  • Provides oversight and QA approval to various systems (CAPA, Deviation) through which quality history and trending are monitored and corrective/preventative actions or quality improvements are recommended, implemented and consistently managed.
  • 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.
  • Provides support to other functions of Quality Assurance department which includes but not limited to the preparation of master documents and the coordination of documentation services through other departments.
  • Promotes and advocates quality achievement and performance improvement across the organization.
  • Participates as required in Health Canada, FDA & customer audits and ensures corrective actions are completed with customer specifications or SOPs.
  • Ensures ongoing compliance with local, national, and international standards and legislation.
  • Other duties as assigned.

 

                         

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

 

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.

 

PLANNING – is the process of thinking about and organizing the activities required to achieve a desired goal.

 

 

   

Other Requirements

 
  • 2-3 years’ relevant experience in a regulated Pharmaceutical industry including Quality Assurance, Quality Control.
  • BSc degree in science or related field, QA courses or training.
  • Knowledge of pharmaceutical QA methodologies, cGMP, Quality Systems, Analytical Chemistry.
  • High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize, and work in team environment, take initiative.
             

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 six 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 nine manufacturing facilities across seven 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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More Info at www.bimedacareers.com

                 

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