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.
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
c. Investigation review/writing including Unplanned
Deviations, Planned Deviations, Comment Records,
Environmental Monitoring Excursions and Equipment
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
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
3. Must be skilled in the use of computers, software and
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
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
AMRI - 2 years ago
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