Quality Assurance Reviewer
Company: Nitto Avecia Pharma Services
Posted on: June 14, 2019
Review GMP technical documentation to ensure quality standards are
met and compliant with applicable SOPs and regulatory
Perform timely review of test results and technical documentation.
Work closely with laboratory management to proactively address the
quality of documentation. Prepare summary of findings noted within
the documentation and report deficiencies to the project leader for
Collaborate effectively with operations management to review and
approve: SOPs, protocols, test methods, reports, change controls,
equipment qualifications and calibrations.
Collaborate closely with functional managers throughout the Company
to execute, review and approve quality investigations.
Maintain workspace cleanliness by adhering to the 5S method of
Abide by safe work practices and adhere to general safety rules,
performing all duties in a safe manner and never placing yourself
or those around you in an unsafe condition. Report all unsafe
conditions to your supervisor.
This list of duties and responsibilities is not all inclusive and
may be expanded to include other duties and responsibilities, as
management may deem necessary.
Accountability - Making a commitment to the organization and
meeting obligations, adhering to policy, and accepting
Ethics & Integrity - Exhibiting personal integrity and
professionalism, aligning with organizational values, and modeling
Interpersonal Competencies - Contributing to the team,
communicating effectively, working cooperatively, resolving
conflict, building team capability, and celebrating success.
Strategic Competencies - Identifying what needs to be done, taking
action, adding value and participating in positive change.
Qualifications - Experience and Education:
A minimum of 4 years, 6+ years preferred, work experience as a
Chemist in the pharmaceutical industry.
Bachelor's degree or equivalent in scientific discipline
Knowledge, Skills, and Abilities:
Developing knowledge of cGMP, FDA regulations, and ICH guidelines
as they pertain to contract laboratory operations.
Developing knowledge of USP, Pharm. Eur. and other compendial
methods and procedures.
Developing knowledge of wet chemistry, chromatography,
spectrometry, calorimetry and/or microbiology testing equipment and
Developing knowledge of root cause investigation and problem
solving; experience in the use of 5 Whys and/or other appropriate
root cause investigation tools.
Developing knowledge in the use of LIMS and electronic
documentation systems (i.e. MasterControl).
Strong interpersonal skills. Must be able to express oral and
written communication in a clear and concise manner and effectively
present information and respond to questions from managers,
customers and employees.
Effective organizational and time management skills with the
ability to multi-task and prioritize assignments as needed.
Proficient in Microsoft Office Suite (Word, Excel, PowerPoint,
Critical thinking skills and good judgment working in an
independent environment while handling Quality Assurance tasks.
Ability to perform routine work with general instructions, requires
detailed instructions on new assignments.
Ability to work effectively under pressure in a rapidly changing
Ability to work well independently and effectively with a wide
variety of colleagues both inter- and intra- departmentally.
Ability to seek critical information from key resources to assist
in problem solving.
Equal Opportunity Employer
Keywords: Nitto Avecia Pharma Services, Irvine , Quality Assurance Reviewer, Other , Irvine, California
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