Quality Assurance Specialist
AMRI - Burlington, MA

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Job Description
: SUMMARY OF FUNCTIONS

The Quality Assurance Specialist is responsible for the review of the following; Unexecuted and Executed Batch Records, ,Incoming Materials Inspection documentation, and Validation/Facility Protocols and Final Reports. The QA Specialist performs weekly walk through inspections of the manufacturing areas and provides support to the visual inspection group as needed. The QA Specialist is also responsible for the review and approval of Deviations, Investigations, and Corrective and Preventive Actions. The QA Specialist interacts with clients for quality related issues, as required. The QA Specialist may be asked to participate in support functions during regulatory inspections.

Job Requirements
: MAJOR DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

1. Responsible for working cross-functionally with Manufacturing, Process Engineering, Facility, Inspection and Project Management on Quality Assurance (QA) activities such as the following:

a. Executed/Unexecuted Batch Record Review.

b. Executed/Unexecuted Validation/Facility Protocols/Reports.

c. Investigation review/writing including Unplanned Deviations, Planned Deviations, Comment Records, Environmental Monitoring Excursions and Equipment Excursions.

d. Review of incoming materials/components.

e. SOP writing, review and revision.

f. Reviewing Change Controls.

g. Reviewing Facility Work Orders prior to filing.

2. The QA Senior Specialist works in coordination with the QA Manager to ensure client timelines are on schedule and attainable.

3. Assist in responsibility for the AMRI compilation of documentation, systems and controls to ensure inspection-ready quality systems (ISO, FDA, QP, EMEA) for domestic and international inspections and registrations.

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.

EDUCATION AND/OR EXPERIENCE

1. Bachelor’s degree.

2. Previous experience within aseptic fill/finish a must.

3. Must be skilled in the use of computers, software and spreadsheets.

4. Must have strong organizational skills and ability to prioritize, schedule and multi-task.

5. Must have a minimum of 5 years of QA experience in a pharmaceutical (cGMP) company.

6. Must be able to work independently with little to no supervision.

7. Previous experience in the review of validation (process, IOPQ) protocols and reports.

8. Knowledgeable in FDA cGMPs (21 CFR, 210/211, 820, and 600); ISO 9001 and 13485 a plus

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