Quality Compliance Associate
- $65,000 - $70,000
- Pasadena, CA
Come join a company where you can influence change and make a difference!
A bit about us:
A leading global manufacturer, marketer and distributor of animal health products and veterinary pharmaceuticals
Why join us?
We have a caring, family culture which ensures employees feel supported in their personal and professional lives. We work through challenges
together and provide a working environment where people feel valued and where they can learn and grow within our business.
together and provide a working environment where people feel valued and where they can learn and grow within our business.
Job Details
Role Summary
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
Requirements
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.
- Investigate both individually and as a team member, deviations, and OOS results to determine product impact, root cause and corrective/preventative actions.
- Monitor QA systems and advises/presents to management team on system performance; publishing metrics/reports regarding performance against set goals.
- Provide 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.
- Promote and advocate 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.
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.
Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.
Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.