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QC Manager

Company:
DK RECRUITING With Diana and Ken
Location:
Mountain View, California, United States
Salary:
discussed upon interview
Posted:
April 15, 2019

Description:

Your job as a quality control Manager would be to ensure product quality to maintain standards set forth by the company's quality systems and as mandated by regulatory agencies.

The focus areas for the Quality Contol Manager will include, but not limited to scheduling and executing an inspection, testing, and documentation of all products manufactured by the company at the Mountain View facility.

Responsibilities:

Hire, develop, train, and evaluate QC personnel.

Supervise and oversee QC personnel in their role for safe and efficient verification, approval, release/disposition of PCT or client products/materials.

Ensure and promote compliance with applicable CGMP and GTP regulations and company and client SOPs.

Work with colleagues in the Allendale facility to assure alignment and continuity in laboratory practice between sites.

Assist in investigation and root cause analysis and oversee timely closure of deviation reports and applicable batch records,

Ensure completion and oversee the review of QC logs.

Ensure completion of all client QC requirements related to GMP cellular product and/or material.

Maintain good client relationships.

Oversee QC role in material disposition via deviation reporting system or client based system if applicable.

Prioritize, schedule and manage multiple projects and resources simultaneously.

Monitor effectiveness of quality systems, change control activities and completion both facility and client specific.

Evaluate and investigate customer complaints and deviations; initiate and coordinate corrective and preventive actions as they relate to the quality control function or as assigned.

Maintain tracking and trending aspects of the deviation reporting system.

With colleagues in the Allendale facility, develop and maintain Key Performance Metrics (KPI) for laboratory testing and evaluation.

Interface with suppliers and in-house production personnel to ensure effective corrective and preventive actions are implemented for recurring product/process discrepancies as applicable.

Interface with operation’s management and upper management in significant deviation resolution and corrective action implementation.

Develop, revise and implement Standard Operating Procedures as related to Quality Control activities.

Knowledge and Experience

BS degree in biological sciences or equivalent.

Minimum 5 years related experience in the pharmaceutical, biologics or related industry.

Proven ability to lead, coach, and motivate employees, clearly, communicate job requirements and effectively

If this job interests you and you are looking for a career change an have the qualifications, please email me your resume along with a cover letter to .