Senior Scientific Associate, Manufacturing Technical Investigations & Analytics

Boston, MA
 

Apex Systems is recruiting a Senior Scientific Associate to work on-site in Boston, MA for a major pharmaceutical company. This is a 9 month contract position with a possibility of extension or full-time.

To apply please email your resume to jblanco@ApexSystems.com

 

Pay: $37-$45/hour, depending on experience, certifications, etc.

Position Summary: 

The Senior Scientific Associate, Manufacturing Technical Investigations and Analytics (MTIA) will have the primary responsibility is to support deviations, CAPAs, executed batch records and to provide continuous manufacturing PAT support at the Vertex Manufacturing Center (VMC).  The Senior Scientific Associate, MTIA reports directly to the Sr. Manager, MTIA.

 

Key Responsibilities:

The responsibilities of this position may include, but are not limited to, the following:

  • Performs Process Analytical Technology (PAT) Operator tasks during GMP manufacture.
  • Lead, write and review deviations and investigations for the VMC, including the Drug Product Facility, Facilities, Materials Management and the Kilo Lab.
  • Develop corrective/preventative action plans (CAPAs) through root cause analysis of deviations.
  • Author and submit revisions to controlled documents in support of GMP Operations, including Standard Operating Procedures, Work Instructions and Master Batch Records.
  • Review executed batch records to ensure compliance with GDP/GMP requirements.
  • Apply GMP concepts and internally aligned interpretations of regulatory guidance to ensure consistent and compliant practices across GMP Operations.
  • Assist team manager with project management tasks, including data analysis, preparation of team presentations, collection and summary of meeting notes

 

Minimum qualifications:

  • BS/MS in chemical, mechanical, or material science engineering or comparable degree.
  • Two or more years experience working in a GMP manufacturing environment in the pharmaceuticals, biotechnology or medical device industries.
  • Understanding of cGMP concepts and general practices.
  • Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.
  • Experience working in Quality Management System for regulated documents (e.g., Veeva or Trackwise) is a plus.
  • Formal training in root cause investigations and technical writing a plus.

 

 

 

 

 

 

 

 

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 employeeservices@apexsystems.com or 844-463-6178.