Quality Engineer (APR & Validation Oversight)

Mayne Pharma

Posted on: December 30, 2020

Closing: January 29, 2021

Salary: Undisclosed

Position Type: Full Time

Job Description

This position provides Quality Assurance oversight of manufacturing, facility, and quality control areas from a validation and systems perspective. The role includes review and approval of key quality system documents and analysis for process improvement and failure reduction activities.

Key Responsibility Areas

  • Annual Product Review Ownership: Capacity to author and review APRs, SOPs, validation documents, and risk assessments for site non-commercial and commercial projects relating to Quality; demonstrated technical writing experience of pharmaceutical documents (e.g. Annual Product Reviews, Risk Assessments, Procedures)
  • People Leadership:  Lead in the development of a culture and supporting systems to drive open communication, participate in intra/inter-departmental idea sharing to build engaged teams; advance and model Mayne Pharma values and leadership commitments; assure the highest levels of quality, safety, compliance and integrity are adhered to in all interactions
  • Process Improvement:  Identify and recommend opportunities for improved efficiencies, client service and teamwork. As assigned, lead various projects requiring inter-departmental inputs and coordination aimed at improving efficiencies, quality and service across the organization
  • Project Coordination:  Coordinate and support CMC regulatory strategy, identifying key issues and remediation activities needed throughout the project/product lifecycle, to project teams and appropriate management levels within and outside of CMC operations

Specific Responsibilities

Responsibilities include, but are not limited to:

  • Identify problems through trend analysis and facilitate independent or team driven problem-solving using root cause analysis
  • Serve as a technical resource for investigations and deviations in all areas of the operation
  • Fulfill expectations, establishes sustainable relationships with clients and team members, maintains effective and meaningful communication channels
  • Interface with internal non-commercial clients, external commercial clients/partners and all levels of internal clients for commercial processes and projects
  • Provide QA review and approval of validation protocols and reports for manufacturing process, cleaning process, equipment and facility validation activities, for new and existing procedures, change controls, deviations and investigations
  • Author APRs, SOPs, validation documents, change controls, statistical and risk assessments for site non-commercial and commercial projects relating to Quality
  • Serve as Quality Assurance representative for new process and system implementations and cross functional improvement teams
  • Seek continuous improvement, adapt quickly to change, and apply sound judgment
  • Receive little direct supervision for most assignments and tasks
  • Ensure compliance to all compendial, internal and client-specific requirements (SOPs, Quality Agreements, General and Informational Chapters in multiple compendia as applicable)

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
  • Attention to Detail:  Ensure information is complete and accurate; follow up with others to ensure that agreements and commitments have been fulfilled
  • Quality: Support Quality and Data Integrity principles in every action and activity, visibly prioritizing quality, helping to transfer and reinforce quality in our environment

Qualifications

  • Master’s Degree in science with six years of relevant experience
  • BS or BA degree in science with eight years of relevant experience
  • Proficient in process and data review within respective scientific field of operation in accordance with job responsibility and function, able to troubleshoot product, process, and/or analytical-related issues
  • Knowledge of pharmaceutical manufacturing processes, validation, and investigational requirements
  • Basic understanding of applied statistics
  • ASQ CQE or CQA certification preferred but not required with appropriate relevant experience

Equal Employment Opportunity and Employment Eligibility 

Mayne Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.  Mayne Pharma also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.  Mayne Pharma is an E-Verify employer.

Mayne Pharma

Posted on: December 30, 2020

Closing: January 29, 2021

Salary($): Undisclosed

Position Type: Full Time

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Career Focus: Engineer, Quality, Validation

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