Job Details

ID #4876685
State North Carolina
City Raleigh / durham / CH
Full-time
Salary USD TBD TBD
Source Civica Rx
Showed 2020-09-23
Date 2020-09-12
Deadline 2020-11-11
Category Et cetera
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Quality Assurance Manager, Raleigh NC

North Carolina, Raleigh / durham / CH 00000 Raleigh / durham / CH USA

Vacancy expired!

Essential Duties and Responsibilities

Establish and maintain appropriate development phase GMP compliance during product manufacture, testing and stability.

Review and assess production and testing methods, specifications, validation protocols for analytical methods, reference materials, test results and reports created during product development.

Routine coordination and quality review of Contract Manufacturer Organization (CMO) Partners’ documentation including batch record review for compliance to facilitate timely disposition of product lots.

Quality Systems : Working knowledge and / or ownership of the following quality systems : Change Control, CAPAs, QA holds, Deviations, Technical Complaints / Adverse Events, Management Monitoring and Self inspection auditing, QA reporting and approval of GMP documentation.

Quality Operations : Support GMP compliance and inspection readiness within organization.

Reviews records to ensure data meets the industry requirements for data integrity.

Provides Quality oversight over software qualification, calibration and validation.

Ensures that procedures are being followed as outlined under FDA, ISO, USP and CGMP guidelines.

Provides input and quality oversight over investigations, which includes review of investigation reports and associated corrective and preventative action (CAPA) plans.

Partners with Quality team members to implement centralized processes and ensures compliance to industry standards and compendia requirements.

Conducts internal audits and external to determine if work activities affecting quality are in compliance with established quality procedures and that the quality management system is operating effectively.

Participates in qualification and approval of suppliers and subcontractors.

Promotes a quality mindset and quality excellence approach to all activities.

Receive, initiate, investigate and conclude product complaint investigations using the current product complaints management software and coordinate all aspects of investigation through closure and / or provide oversight for complaint handling process.

Travel (up to 10-20%) may be required, including international travel.

Basic Qualifications

Bachelor’s degree in a scientific discipline with a minimum of 5 years Quality / CGMP experience in the pharmaceutical industry.

Experience in the manufacture of sterile injectable pharmaceutical products.

Experience with analytical QC (method development, validation and sample analysis)

Demonstrated quality experience with injectable pharmaceutical product experience.

Minimum of 2 years’ experience in a supervisory role

Excellent written / oral communication skills with a strong discipline in Microsoft Programs is required.

Self-motivated, flexible, and able to work in a small, fast-paced, dynamic, environment.

Ability to work autonomously within established guidelines, procedures and practices.

Committed to delivering high quality results, overcoming challenges and focusing on what matters.

Continuously looking for opportunities to learn, build skills and share learning.

Preferred Qualifications :

Experience with Medical Device a plus

Salary DOE

Vacancy expired!

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