QA Specialist

Position Summary:

The Quality Specialist performs critical QA compliance tasks in support of GMP manufacturing programs. This position works closely with Manufacturing, Quality Control, and Materials Management teams to help ensure high quality standards and value delivery for our customers. recommends changes in standards, processes, equipment and materials to facilitate work and maintain quality. The role also interacts with other supervisors, managers and technicians to determine and resolve quality related issues.

Key Responsibilities:

· Perform reviews of all In-process and Final Product testing for accuracy and completeness in a timely manner to meet company objectives.

· Write, implement, and/or edit SOPs as needed or for continuous improvement efforts.

· Act as a subject matter expert for QC testing assays and assist with troubleshooting issues, assay verification, and perform training and testing assays if needed.

· Perform equipment validation as needed.

· Spearheading actions to compile data, document results, report on and close the company's process deviations, NCRs, CAPAs and Complaints.

· Verify implementation of corrective actions to ensure continuous improvement

· Maintain the quality system in a state of inspection readiness by ensuring ongoing compliance with FDA, current ISO 13485, and IVDD/IVDR regulations.

· Review and approve quality control assay data and file as necessary, report non-conformances, file completed quality records and maintain data trending databases and records.

· Maintain and systematically review relevant department SOPs and coordinate with QA/QC/RA Department on revisions when required.

· Actively participates in continuous improvement opportunities to identify efficiencies and compliance improvements to benefit department operations or the organization at large.

· Performs other duties as assigned.

· Contribute to the maintenance of the company's process deviation, NCR, CAPA and Complaint systems, and verify implementation of corrective actions to ensure continuous improvement.

Education:

· Bachelor’s Degree in life sciences related field required

Experience:

· 3-5 years’ experience in Quality in GMP environment

Minimum Requirements/Qualifications:

· Working knowledge of current ISO 13485, FDA 21 CFR 820, and IVDD/IVDR regulations. Ability to respond to internal and external quality audits and perform root cause analysis and risk assessment activities.

· Knowledge of QC testing procedures, current ISO 13485, and 21 CFR Part 820 regulations.

· Proficient with Microsoft Office software; experience building and using databases (e.g. Microsoft Access, Excel) preferred.

· Excellent technical writing, communication, and organizational skills.

· Attention to detail is a must.

· Hands-on approach to troubleshooting and resolving quality related issues.

· Detail and Quality focused with strong organization, persuasion and negotiation skills.

· Ability to present information and respond to questions from various levels within the organization.

· Thrives in a fast-paced, collaborative environment, efficiently works under pressure, within deadlines or other time essential constraints.

· Excellent communication skills, both written and verbal, to clearly and concisely communicate to all levels of the organization.

· Strong work ethic and an ability to excel within a rapidly changing and growing organization.

Job Type: Full-time

Pay: From $32.00 per hour

Schedule:

• 8 hour shift
• Day shift

Work Location: In person

Salary : $32