Manager. QA, R&D

Purpose: There is an immediate opening for a QA Manager in the R&D Department for a pharmaceutical company located in Costa Mesa, CA. This position will assure quality and adherence to regulatory compliance in the research and development of pharmaceutical products. Asssist in the implementation of quality programs and provide assessment of vendor's qualification an compliance. Work collaboratively with R&D departments' managers, directors and V.P. to support division strategic goals.

RESPONSIBILITIES:

-Work collaboratively with R&D departments' managers in the assessment of vendors' qualifications. Perform vendors' audits to assess performance and compliance to regulatory requirements and business contract terms.

-Perform GXP audits, including clinical investigator sites, CRO audits, and vendor audits during on-going activities.

-Develop quality assurance audit plan, perform audit, write audit reports and issue audit findings, follow through to verify corrective actions and closures of issues, track and monitor performance.

-Provide inputs toward the development of R&D quality system processes. Develop and write R&D QA SOPs.

-Participate or lead the internal audit of R&D quality systems and departmental operations.

-Participate in the investigation of non-compliance issues. Provide recommendations for the corrective and preventative actions to bring operations into compliance.

-Perform review and provide input to the documents developed during the conduct of pre-clinical and clinical studies.

-Perform review of scientific reports, audit data and provide input pertaining to data/report accuracy and sound scientific conclusion.

-Perform review of reports and assure quality submission of regulatory affairs documents.


OTHER DUTIES:

-Assist in the mentoring of junior departmental staff and cross-training of other QA auditors to support R&D projects.

-Support the continuous process improvement initiatives in the strive toward Lean Six Sigma Excellence.

EDUCATION:

-B. S./M. S. degree in scientific disciplines with at least 6 years of relevant industry experienceClassification:Direct PlacementCompensation:
65K-75K YearJoin Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries is an equal opportunity employer.

Required Qualifications:
Skills Requirements:
QA MANAGERContact Information
Contact:Rodriguez,Candi M