This site uses cookies. To find out more, see our Cookies Policy

GMP Quality Investigator - CAPAs, Six Sigma, deviations in Andover, MA at Apex Life Sciences

Date Posted: 12/13/2018

Job Snapshot

Job Description


Apex Life Sciences is seeking a Lead GMP Investigator to work in an Investigations group for a top Pharmaceutical company. This group is responsible for overseeing investigations for all GMP manufacturing suites in Andover, including both mammalian and bacterial based processes in support of commercial and clinical Drug Substance manufacture.

Responsibilities

  • Responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports.
  • Responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports.
  • Develop collaborative relationships with the operational leadership and staff in each suite and the appropriate Quality and Functional Area representatives in order to facilitate investigations using continuous improvement techniques.
  • Utilize experience in the area of quality and compliance and a working knowledge of the appropriate regulations.
  • Assist in continually defining and improving the philosophy and justifications involved in investigations and to continually evolve to meet changing business needs.
  • Work with the appropriate people from both the quality and operational organizations develop a corrective action
  • Ensure investigations are conducted with a strict adherence to appropriate quality and compliance standards
  • Exercise judgment in developing practices, techniques and evaluation criteria for obtaining results

Qualifications

  • A BS or MS, preferably in a scientific or engineering discipline preferable. A minimum qualifications to BS + 4-6 yrs experience or MS + 2-4 yrs experience in a pharmaceutical and/or biological manufacturing operation with a strong technical background in a cGMP and Quality environment is required.
  • Experience with and in depth understanding of cell culture and chromatography is highly desirable.
  • Prior experience with investigations including conducting and writing investigations and in use of continuous improve methodology preferred.
  • Must be a collaborative team player with strong coordination, facilitation and writing skills.
  • Should have a fundamental understanding of the investigation process as it applies to manufacturing issues
  • Must have detailed understanding of the processes and systems involved in the manufacture of bio pharmaceutical. Be able to use that knowledge to investigate process deviations and atypical results and identify root cause

***For immediate consideration, please email your updated resume to Ljohnson@apexlifesciences.com with 'GMP Quality Investigator MA' in the subject line.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




913918