QA Associate

Bimeda, Inc.; Pomona, Northern (CA, KY); Hybrid; USD 65,000 - 85,000; Full time

Benefits offered by this job

401(k) plan for retirement savings

Paid time off (vacation, sick leave, &

Life insurance

Employee assistance program

Job summary

Bimeda, Inc. in Pomona, CA is seeking a QA Associate to join the in-office quality team. The role covers product release, change control, APRs, deviations and CAPA, and the rollout of electronic systems (e-QMS, LIMS, EBR) to enable data-driven decisions.

The ideal candidate will bring GMP experience, a strong quality mindset, and the ability to drive continuous improvement within a lean quality organization.

Qualifications

• University degree in a related science field with QA education or training.
• Knowledge of pharmaceutical QA methodologies, cGMP regulations, and quality systems.
• Minimum 2–3 years of experience in pharmaceutical QA systems, document control, and GMP compliance.
• Proficiency in Microsoft Office and document management systems.
• ASQ certification (CQA, CQE) or equivalent quality certification is a plus.

Responsibilities

• Conduct product release and batch review under GMP.
• Lead change control initiatives and support e-QMS implementation.
• Perform internal QA audits on manufacturing lines and finished products.
• Investigate deviations, CAPA, and OOS results and drive corrective actions.
• Support digital transformation with e-QMS, LIMS, and EBR adoption.
• Provide training to operators on documentation and cGMP requirements.

Skills

Attention to detail

Documentation

Microsoft Office

Cross-functional collaboration

Data analysis

Education

Bachelor's degree in related science

QA education or training

Tools

ZenQMS

TrackWise

MasterControl

LIMS

Electronic Batch Records (EBR)

Job description

Pomona, CA,United States | Full-time regular

Job Title: QA Associate (Quality Assurance)
Location: Pomona, CA (In-office)
Position Type: Full-time
Vacancy Status: This position is vacant
AI Disclosure in Hiring: We use artificial intelligence to screen, assess and select applicants

Job Summary

Reporting to the QA Manager, the QA Associate works within an established culture of QA and continuous improvement in all GMP areas The role owns core GMP responsibilities, including product release, change control, Annual Product Reviews (APRs), and deviation and CAPA resolution, while also supporting the adoption of electronic quality systems (e-QMS, LIMS, and electronic batch records), advancing data-driven and risk-based decision-making, and championing a culture of continuous improvement. This is an opportunity for a quality professional who is energized by modernization, comfortable challenging established processes, and ready to help build a leaner, more capable quality organization for the future.

Role Specific Requirements

Product Release, Change Control and Quality Systems

• Conduct Annual Product Reviews (APRs) by analyzing production documentation, summarizing key issues and trends, and preparing final reports, incorporating quality metrics and trending data where available.
• Perform batch record review and determine batch disposition (release, reject, or hold) based on quality and risk impact; support the shift toward risk-based, exception-driven batch review as electronic batch records (EBR) are implemented.
• Provide oversight and QA approval for CAPA, deviation, and change control systems; monitor quality history and trends, and recommend data-driven improvements.
• Lead change control initiatives and facilitate documentation workflows in the e-QMS, supporting the site's transition to a fully electronic quality management system.
• Administer and maintain GMP documents (Policies, Corporate SOPs) and quality records within ZenQMS, supporting the ongoing digitization and simplification of the site's document library.

Investigations, Audits and Inspection Readiness

• Investigate product complaints, deviations, and OOS results to determine root cause, quality impact, and corrective and preventive actions.
• Perform internal QA audits on manufacturing lines and finished products to verify compliance with corporate policies and GMP requirements.
• Participate in regulatory, customer, and internal/mock audits; ensure timely completion and effectiveness verification of corrective actions.
• Support the site's quality initiatives and broader inspection-readiness activities, including SOP framework reapproval and CAPA effectiveness tracking.
• Ensure ongoing compliance with local, national, and international cGMP standards and legislation.

Digital Transformation and Continuous Improvement

• Support the implementation and adoption of e-QMS, LIMS, and electronic batch records, helping shift routine administrative work toward risk-based technical review and decision-making.
• Use quality metrics, trend analysis, and dashboard or reporting tools, including AI-assisted quality analytics where available, to identify patterns, flag emerging risks, and inform data-driven decisions.
• Champion quality culture initiatives such as Gemba walks, Quality Minutes, and Good Quality Catch recognition; support classification and reduction of human-error deviations.
• Assist with development, simplification, and continuous improvement of departmental procedures, SOPs, and best practices, with a focus on reducing manual and administrative burden.
• Proactively identify opportunities to simplify, automate, or eliminate manual quality processes; act as a change agent who is comfortable challenging legacy ways of working in support of a leaner, more capable quality organization.
• Support cross-training and knowledge-sharing efforts to reduce single-point dependencies and build a more flexible, resilient quality team.

Partnership, Training and Communication

• Collaborate with client-facing QA representatives and cross-functional partners in Manufacturing, QC, and Regulatory to ensure product and service quality and customer satisfaction.
• Provide training and coaching to operators and supervisors on documentation practices, cGMP requirements, and evolving digital quality tools and workflows.
• Communicate quality and documentation requirements clearly to internal teams and customers.
• Promote quality achievement and continuous improvement across the organization; serve as a visible advocate for quality as a shared value woven into everyday decisions.

Additional Notes

• Working conditions: warehouse and production environments. Exposure to noise, chemicals, and machinery. PPE required in certain areas.
• Physical demands: Walking, standing, occasional lifting (up to 50 pounds).
• May require work outside regular hours or weekends.

Competencies Required for the Role

EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen, and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.

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.

EXECUTION/ACCOUNTABILITY – A willingness to accept responsibility or to account for one’s actions. Accountability is when an individual or a department experiences consequences for their performance or actions.

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.

DRIVING CHANGE/CONTINUOUS IMPROVEMENT – The drive to challenge established processes and the status quo in pursuit of better outcomes; comfort adopting automation, digital tools, and data-driven approaches; the agility to adapt quickly to evolving systems, priorities, and organizational structure; and a mindset that treats modernization as an opportunity rather than a disruption.

What We Are Looking For

Required :

• University degree in a related science field with specific Quality Assurance education or training.
• Knowledge of pharmaceutical QA methodologies, cGMP regulations, and quality systems.
• Strong attention to detail, organizational skills, and ability to manage timelines and priorities.
• Proficiency in Microsoft Office and document management systems.
• Minimum 2–3 years of experience in pharmaceutical QA systems, document control, and GMP compliance.

Preferred:

• Experience with electronic quality systems (such as ZenQMS, TrackWise, or MasterControl), LIMS, or electronic batch record (EBR) platforms.
• Experience using data analytics, trending, dashboards, or AI-assisted quality tools to support risk-based decision-making.
• Demonstrated experience supporting or driving process improvement, automation, or digital transformation initiatives in a regulated environment.
• A track record as a change agent, someone who has identified and driven improvements to legacy processes rather than simply maintaining them.
• ASQ certification (CQA, CQE) or equivalent quality certification is a plus.

What We Offer

• 401(k) plan for retirement savings
• Paid time off (vacation, sick leave, holidays)
• Life insurance
• Employee assistance program

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.

Bimeda is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), sexual orientation, gender identity or expression, age, national origin, ancestry, citizenship, physical or mental disability, medical condition, genetic information, marital status, military or veteran status, or any other basis protected by applicable federal, state, or local law.

We value diverse perspectives and encourage applications from people of all backgrounds, experiences, and abilities. If you need a reasonable accommodation to participate in the application or interview process, please contact us at [e-mail] .