Quality Assurance Specialist

Mayne Pharma - Greenville, NC2.9

Full-timeEstimated: $57,000 - $78,000 a year
Position Overview

This position requires the ability perform established routine and non-routine Quality Assurance tasks with minimal supervision in support of internal non-commercial clients, external clients and/or commercial processes and projects as assigned.

Key Responsibility Areas

Routine Quality Review: Provide timely and careful review of routine laboratory, product development and manufacturing work output to assure the highest standards of quality are met or exceeded and in compliance with regulatory requirements; escalate issues as necessary and partner with operational teams to correct issues
Non-Routine Quality Review: Provide timely and careful review of more complex laboratory, product development and manufacturing work output to assure the highest standards of quality are met or exceeded and in compliance with regulatory requirements. Escalates issues as necessary and partners with operational teams to correct issues.
Proactive Operational Support: Develop partnerships with operational teams to provide proactive guidance and direction to assure the quality standards are known and understood from inception to completion
Quality Advocacy: Provide broad advocacy for the continued improvement of quality standards and the development and maintenance of a quality culture across the organization
CAPA Remediation: As assigned and under general supervision, participate in the development and implementation of corrective and preventative actions around quality deviances
Specific Responsibilities

Responsibilities include, but are not limited to:
Follow all regulatory guidelines, cGMP guidelines, EH&S and local regulations as required
Provide assistance to development, operations, laboratories and validation groups with appropriate quality oversight through review, approval and release of records, reports, and completed packets as assigned
Provide real-time support activities for production lines, analytical laboratories and pharmaceutical development operations
Escalate unplanned events and issues, providing immediate notification to QA Supervisor and Manager, supporting and providing guidance to operations, development and laboratory staff as assigned
Review Quality documentation including but not limited to review and release of Batch Records, release of equipment, room set up, room clearance, initial documentation of unplanned events as appropriate
Assist and support Internal Audit program, assure timely completion of CAPA items as assigned
Remain proficient and knowledgeable within respective field of operation in accordance with job responsibility and function, able to troubleshoot process, system, material and technique-related issues
Act as QA representative on project teams, providing Quality guidance and support while working to facilitate lean processes

Key Competencies/Requirements:
Accountability: Assume responsibility for successfully accomplishing work objectives and delivering business results; setting high standards of performance for self and others
Agility: Respond positively to change, embracing and using new practices or values to accomplish goals and solve problems
Creativity: Explore and advances opportunities to develop novel solutions and approaches to the improvement of processes and services
Empowerment: Find opportunities to improve and extend their contribution to the organization and their teammates
Integrity: Demonstrate the highest commitment to integrity and showing respect for and value all individuals for their diverse backgrounds, experiences, styles, approaches and ideas
Passion: Evidence passion for the organization, our people, and the difference we make daily in improving the lives and health of people
Communication: Deliver clear, effective communication and take responsibility for understanding others
Teamwork: Work well with others while providing support and assistance to team members to help accomplish objectives

Bachelor degree in chemistry or related field with four years of professional experience in the pharmaceutical industry, preferably with two years in a QA role
Associate degree in chemistry or related field with seven years of professional experience in the pharmaceutical industry, preferably with three years in a QA role
A combination of education and experience may be considered equivalent
Preferred Qualifications
Experienced in review of laboratory investigations and deviations
Attentive to detail, able to recognize critical attributes, steps and functions relating to laboratory processes and activities
Knowledgeable of root cause analysis techniques to support analytical investigation teams
Knowledgeable of cGMPs and application of good documentation practices within pharmaceutical industry
General Statement

Mayne Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.