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Quality Assurance Reviewer

Company: Nitto Avecia Pharma Services
Location: Irvine
Posted on: June 14, 2019

Job Description:

Review GMP technical documentation to ensure quality standards are met and compliant with applicable SOPs and regulatory requirements.

Responsibilities:

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 correction.

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 organization.

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.

Core Competencies:

Accountability - Making a commitment to the organization and meeting obligations, adhering to policy, and accepting responsibility.

Ethics & Integrity - Exhibiting personal integrity and professionalism, aligning with organizational values, and modeling ethical behavior.

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 required.

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 methodology.

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, Project, etc.).

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 environment.

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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