QA Associate III
Company: Sirius Technical Services
Posted on: June 12, 2021
Sirius Technical Services is currently seeking a Quality
Assurance Associate III for a long-term
contract opportunity in Alabaster, Alabama.
Please contact me for more information!
Essential Duties and
- Perform Document Control for Batch Production Records
(BPRs), Standard Operating Procedures (SOPs), Raw Material (RM),
Avanti Product (AP) specifications and Job
- Conduct product releases/rejection including review of
batch production documents, review of analytical results, and
comparison to specifications.
- May be tasked with the design, development and delivery
of high quality and high impact training programs and services that
provide functional, GMP and product knowledge for employees to
achieve a high level of performance in their
- Implement and follow the Corrective and Preventive Action
Program (CAPA) process to ensure effective and timely closure of
- Oversight of Facility / Equipment qualification. May be
required to help develop and/or review/approve User Requirements
Specifications, as well as IQ/OQ/DQ documents.
- Conduct Annual Product Review.
- Provide QA input for product shipments including product
release, label preparation, review and application, final label
review, shipment packaging, and shipment paperwork.
- Write and revise BPRs, SOPs, RM specs, AP specs and Job
Descriptions on a timely basis.
- Perform annual document reviews (when required by quality
- Perform internal audits.
- Conduct raw material qualification and vendor
- Prepare for and assist during customer / FDA
- Review / Approve Out-of-Specification (OOS)
- Perform Change Control (review and approval of Deviations
and Change Requests).
- Perform process / method validation program (including
design and review of validation efforts).
- May maintain or assist in the maintenance of calibration
and maintenance database for equipment to ensure that equipment and
instruments are fit for use.
- Keep personal training up-to-date using Quality
Management tools provided.
- Follow all written policies delivered by Management
and/or Regulatory Affairs (Standard Operating Procedures, Chemical
Hygiene Plan, Emergency Contingency Plan, training memoranda,
policy memoranda, Material Safety Data Sheets, Specification
- Generate quality metrics using specific
systems/applications by obtaining raw data, developing quality
monitoring database and creating appropriate level reports using MS
Excel (pivot tables, charts, graphs, etc.) or other software
- Perform or participate in investigations using various
tools such as root cause analysis, Failure Mode and Effects
- Assess causes systemically, looking beyond the obvious to
determine why people, processes and/or systems are not meeting
- Analyze resulting quality metrics and assess
- Work with supervisors of departments to ensure
consistency and close gaps in coaching and training.
- Provide ongoing analysis of data resulting from the
quality systems review. Communicate results of analysis to
- Assist GMP work areas in developing, implementing, and
maintaining On-the-Job Training (OJT) programs.
- QA Associate III personnel are expected to assist in the
development of junior colleagues and, as assigned by QA Management,
take leadership on special projects and routine
- Provide new hire GMP training for employees.
- Other responsibilities that are outlined in one or more
different Job Descriptions may be
Degree required in the field
of natural sciences, engineer or management
of 10 plus years’
experience in quality or operations, primarily in a cGMP
- Pharmaceutical operations experience
and/or knowledge required.
- Good knowledge of FDA
- Prior CAPA / Investigation oversight experience
- Experience in collecting, analyzing, and presenting data
and recommendations to management.
Sirius Technical Services Inc. is an equal
opportunity employer. All qualified applicants will receive
consideration for employment without regard to characteristics such
as race, color, national origin, religion, gender, age, marital
status, disability, veteran status, citizenship status, sexual
orientation, gender identity, or any other status protected by
Keywords: Sirius Technical Services, Birmingham , QA Associate III, Other , Alabaster, Alabama
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