Quality Assurance Associate jobs in United States
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Bimeda · 8 hours ago

Quality Assurance Associate

Bimeda is a leading global innovator in veterinary pharmaceuticals and animal health products. The QA Associate will work under the QA Supervisor, focusing on quality assurance processes, compliance with GMP standards, and coaching staff on documentation practices.

BiotechnologyHealth CareManufacturingPharmaceuticalVeterinary

Responsibilities

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

Qualification

CGMP regulationsQuality Assurance systemsAnalytical thinkingQuality auditsProblem-solvingMicrosoft OfficeTeamworkEffective communicationAttention to detailSelf-motivated

Required

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
Bachelor's degree in a related Science or equivalent experience

Benefits

Health Insurance (medical, dental, vision)
401(k) plan for retirement savings
Paid time off (vacation, sick leave, holidays)
Life insurance
Employee assistance program

Company

Bimeda

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Bimeda manufactures and develops a wide range of animal health products that includes veterinary pharmaceuticals and nutritions.

Funding

Current Stage
Late Stage

Leadership Team

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Gavin Tierney
Group Chief Executive Officer at Bimeda Animal Health Ltd
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Sarah Louise Nielsen
Personal Assistant to CEO
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Company data provided by crunchbase