Qa Technician Ii

The Quality Assurance Technician II will be primarily responsible for bulk release processes, including test requirement determination, bulk dispositioning, Manufacturer Certificate of Analysis and receiving document review, sampling, release process for direct-to-stock items and container / closure repack components, and in-house identification testing. The Quality Assurance Technician II shall also support finished good and label release processes, and Letco Certificate of Analysis approvals.

Primary Duties and Responsibilities:

1. Provides bulk receipt disposition notifications.
2. Performs physical inspections of bulk containers and disposition labeling.
3. Maintains Manufacturer Certificate of Analysis document files.
4. Creates test sample labels as required.
5. Determines test requirements of bulk, reviews test results, and completes applicable test sample documentation.
6. Performs bulk sampling, including staging.
7. Reviews Manufacturer Certificate of Analysis against applicable compendia monograph and associated receiving documents for accuracy.
8. Performs in house identification testing using a TruScan RM Spectrometer.
9. Performs inspection and disposition of direct to stock chemicals.
10. Performs inspections, tests, and disposition of container / closure repack components.
11. Reviews Letco labels for accuracy and approval.
12. Creates or reviews and approves Letco Certificates of Analysis.
13. Assists with inspection and disposition of item returns.
14. Assists with organization of the document control storage room and server files.
15. Performs facility and health check audits and reports results as required.
16. Performs initial investigations for customer and supplier complaints as assigned.
17. Assists in investigations of internal quality issues as required.
18. Provides quality support to Production, including production event assessment, item inspections, room inspections, etc. as needed.
19. Performs QA Sample Room housekeeping or inspections for cleanliness as required.
20. Documents quality assessments and finding reviews for complaint investigations, including creation of customer response letters for approval, as assigned.
21. Reviews for disposition of blank media label receipts.
22. Serves as a primary backup support for the Quality Assurance Technician I.
23. Assists with finished goods release process, including batch record and record disposition, maintenance of retain sample program, and inspection of finished good units.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

1. Experience and Educational Requirements: High School Diploma or GED equivalent required; Associate Degree or Bachelor’s Degree in a science related field or industry equivalent experience preferred; minimum of two (2) years of progressive responsibilities in quality assurance / control experience preferred; or an equivalent combination of education and experience. Experience in the pharmaceutical industry a plus.
2. Language Ability: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals.
3. Math Ability: Ability to work with mathematical concepts such as probability and statistical inference and apply the concepts to practical situations.
4. Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
5. Computer Skills: To perform this job successfully, an individual should be proficient in the Microsoft Office suite of applications including Word, Excel, PowerPoint and Outlook and with Internet Explorer.

Physical & Mental Requirements: The physical demands described here are representative of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions:

1. Sedentary and physical activity requiring reaching, sifting, lifting, finger dexterity, grasping, feeling, repetitive motions, talking and hearing.
2. Ability to lift and/or maneuver up to 50lbs.
3. Visual requirement is for close vision, distance vision, peripheral vision and ability to adjust focus.
4. 10% or more time is spent looking directly at a computer.
5. Associate is occasionally required to stand, walk (or otherwise be mobile).
6. Ability to deal with stressful situations as they arise.