Quality Assurance Professional

Actual Job Title: QC Analyst



1st Shift: 8:00am-4:30pm



Conducts routine and non-routine analysis including but not limited to biochemical and chemical analysis of raw materials, in-process materials, and finished products according to established operating procedures. Compiles data for documentation of test procedures including stability program testing. Calibrates and maintains lab and analytical equipment. Participate in preparation of failure and complaint investigations, summaries and reports abnormalities. Revises and updates standard operating procedures as needed. May perform special projects on analytical and instrument problem solving, and develop testing and analysis methods and procedures in accordance with established guidelines.



Position Responsibilities:

1. Test finished products for precision and performance.

2. Analyze test results and prepare test batch records.

3. Process and analyze data using basic statistical methods and internal software.

4. Analyze in-line testing rotor lot data for lot release and issuing performance results.

5. Support the company s retention program, ensuring well organized storage of samples.

6. Initiate, perform, and monitor stability studies and program in compliance with applicable regulations and proactively notify appropriate functional management of emerging issues.

7. Test and release incoming raw materials (enzymes and reagents).

8. Initiate and assist in resolving non-conformance related to QC inspection.

9. Test, analyze and submit Proficiency Survey samples (CAP and API).

10. Maintain equipment and lab supplies inventory.

11. Support troubleshooting and assigned projects.

12. Review instrument production logs, analyze and report abonormalities.

13. Maintain current knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).

14. Other duties as assigned.



This position will need to achieve results through colleagues with a direct reporting relationship (site QC team) as well as indirectly. The successful candidate will need to interact regularly with leadership at the site, GMT, Client, and regulatory affairs to ensure quality goals and objectives are met.



Education and Experience:

Bachelor of Science in Chemistry, Biochemistry, Biology or any other relevant scientific discipline with 2+ years of quality control and analytical laboratory experience.

Experience with in-vitro diagnostics preferred.



Technical Skills and Competencies Required

Strong attention to details and numbers.

Laboratory and technical competence including basic statistical analysis.

Working knowledge of basic computer programs such as Microsoft Word, PowerPoint, Excel, and Outlook.

Effective and clear written and communication skills

Ability to perform routine responsibilities independently with minimal supervision

Ability to complete tasks on time to keep commitments.

Flexibility to prioritize and plan work activities.

Deliver thorough, accurate, and complete work output with minimal errors and attention to detail.



This position will require fluent use of LIMS and IT tools, teleconferencing tools, as well as SharePoint technologies to share and manage information with Global QC Network and Quality Organization. This position will also require to lift or move materials weighing up to 50 lbs. This position regularly required to stand, walk and sit to perform the tasks. Specific vision ability required include depth perception and color vision.