Quality Assurance Associate

Bimeda, Inc.; Minnesota; On-site; USD 60,000 - 75,000; Full time

Benefits offered by this job

401(k) plan for retirement savings

Paid time off

Life insurance

Employee assistance program

Job summary

Bimeda, Inc. in Minnesota is seeking a QA Associate to join a GMP-driven Quality Assurance team. The role covers change control, facility compliance, product and material release, deviation resolution, and ensuring cGMP standards are met.

You will coach operators on proper documentation practices to ensure manufacturing compliance. Requirements include 1+ year in pharmaceutical or food QA, cGMP knowledge, and a bachelor’s degree in a related science.

Qualifications

• 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.

Responsibilities

• Assess potential impact of incidents and processing deviations on product quality and release status.
• Conduct incoming inspection of printed labelling to determine acceptability.
• Interact with label vendors to resolve problems.
• Investigate product complaints, deviations, and OOS results to determine root cause and corrective actions.
• Perform internal quality audits compliant with policies and procedures.
• Promote quality achievement and performance improvement across the organization.
• Ensure ongoing compliance with local, national, and international standards and legislation.
• Participate in audits/inspections and ensure corrective actions are completed.
• Perform initial inspection of packaging lines for SOP compliance.
• Assist with resolution of compliance issues related to manufacturing lines.
• Write, review, and revise SOPs and related forms for job activities.
• Support Continuous Improvement program.
• Review batch documentation for cGMP compliance and resolve discrepancies.
• Perform QA release of finished product for acceptable materials and manage outgoing pallets documentation.
• Prepare raw materials and finished product samples for QC and monitor testing and documentation.

Skills

QA Experience

cGMP knowledge

Analytical thinking

Detail oriented

Cross-functional interfacing

Excel

Education

Bachelor’s degree in a related Science

Tools

Microsoft Office

Excel

PowerPoint

Job description

Role Summary

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.

Shift Availability

Afternoon Shift: Monday - Friday, 3:00PM - 11:30PM

Key Role Specific Requirements

• 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.

What We’re Looking For

Required Skills:

• 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

Educational Requirements

• Bachelor’s degree in a related Science or equivalent experience.

Competencies Required for the Role

FOSTERING COLLABORATION/TEAMWORK - 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.

EFFECTIVE COMMUNICATION - 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.

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 - 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 and information are complete and accurate, carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.

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.

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 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 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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Bimeda is an equal opportunity employer committed to fostering a diverse workforce. All qualified applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.