*DIRECT HIRE* QA Specialist with GCP

Are you ready to take a step forward with a well respected, innovative, research-based global pharmaceutical company?

Immediate opportunity for a QA Specialist with a knowledge of GCP's!

Position Summary:
Assure quality and adherence to regulatory compliance in the research and development of pharmaceutical products. Assist in the implementation of company quality programs. Provide assessment of vendor's qualification and 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 preventive 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.

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.

Qualifications:

B.S./M.S. degree in scientific disciplines with at least 6 years of relevant industry experience.

Must have GCP experience/knowledge.

Demonstrated leadership skill and ability to implement projects.

Ability to interact with staff, functional peer groups at various management levels, service providers, consultant auditors, and outside regulatory agencies.

Excellent communication and organizational skills.




job Requirements


Please refer to the job description above.