Job Description
Under minimal supervision, the Quality Assurance Specialist II will ensure systems and processes are in a state of compliance with regard to internal, regulatory, and industry standards. He/she will promote a culture of quality for the Company. Candidates in this position will routinely report on the performance of the Quality System to senior leadership. Additionally, candidates will identify CAPAs, Deviations, Investigations, Change Controls, Process Improvements, and Root Cause Analysis. Candidates will participate in both internal (annual, in-process, for cause, etc.) and external (client, regulatory agencies, accreditation bodies, etc.) audits.
Essential Duties/Responsibilities:
Participate in all aspects of Quality Assurance to ensure regulatory activities are performed in compliance with both internal procedures and external cGXP/ISO requirements.
Audit various reports prior to issuance (e.g. analysis reports, method validation reports, research and development reports (as needed), special project reports, etc.). Serve as site contact for quality inquiries on analytical reports and related documentation.
Maintain site-specific procedures including the Quality Manual, Standard Operating Procedures, and other site-specific Quality Assurance documents.
Create, revise, review, and approve newly written documents and document revisions.
Work with Operations Management to maintain the training program and ensure that laboratory personnel performing tests have completed all necessary training requirements.
Train laboratory personnel in GXP/ISO procedures, practices, and guidelines.
Participate in the internal auditing program to ensure the established techniques are followed and understood.
Audit methods, work instructions, deviations, investigations, corrective actions, preventative actions, risk assessments, and instrument qualification/calibration paperwork.
Participate in the planning, preparation, and hosting of customer and regulatory audits; respond to audit reports and implement resolution of audit findings.
Assist senior leadership in preparing for the Management Review process.
Assist senior leadership in maintaining the laboratory proficiency testing program.
Collect, track, and analyze quality metrics (OOS, deviations, complaints, etc.) and train
laboratory personnel, as needed to help reduce quality events.
Monitor laboratory compliance with respect to lab cleanliness, training records, and other ISO/GMP-related items, as needed to help minimize laboratory errors and audit findings.
Support quality event investigations to completion using formal root cause analysis tools.
Support periodic summaries of audit outcomes and risk statements that identify whether there are uncontrolled risks within the QMS.
Assist senior leadership in maintaining the list of approved suppliers and subcontractors.
Exist as a backup for all other Quality Assurance personnel.
Qualifications
Capabilities:
Must be a detail-oriented, self-initiating individual with strong interpersonal written and oral communication skills.
Strong organizational skills, and ability to multitask in a dynamic, fast-paced
environment.
Displays sound judgment and ambition; is quality focused; displays good communication skills; good implementation and follow-up skills.
Hands-on experience and strong understanding of industry regulations and how to apply them including 21 CFR Part 11, 21 CFR Part 820, ISO 17025, and GxP.
Hands-on experience with CAPA, change control, quality events, and validation documentation (IQ/OQ/PQ).
Strong problem-solving skills include root cause analysis using formal RCA
tools such as Ishikawa and 5Ys.
Basic Minimum Qualifications:
Preferred:
Additional Information
** _ _Working schedule will be Mon-Fri, 8:00am-5:00pm with occasional overtime as required. Candidates currently living within a commutable distance of San Diego, CA are encouraged to apply.__**
What we Offer:
Eurofins USA BioPharma Services is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.