Quality Control Chemist I in Andover, MA at Pyramid Consulting, Inc

Date Posted: 7/29/2020

Job Snapshot

Job Description

Immediate need for a Quality Control Chemist I with experience in the Pharmaceutical Industry. This is 18+ Months Contract position with possible extension located in Andover, MA. Please review the job description below:

JOB ID # 20-18790

Key Responsibilities and Requirements:
  • Authoring Corrective & Preventive Action plans (CAPAs) for systems with long-term remediation activities, and authoring final reports for systems with short term/completed remediations
  • Performing supporting remediation work in the form of SOP revisions as well as authoring and executing change controls and validation test plans/protocols when required per remediation plans
  • Develop, drive and perform comparability studies for implementation of analytical assays on new instrumentation.
  • Strong working knowledge of the validation lifecycle including computer system validation, 21 CFR Parts 210 and 211, and Part 11, Electronic Records and Electronic Signatures.
  • Working knowledge of data integrity regulations, guidance, and principles
  • Working knowledge of CAPA and change control processes
  • Strong interpersonal, oral and written communication skills as there is a high degree of collaboration required between members of QC, QA Validation, Instrument Validation, and IS/IT functions.
  • Knowledge and experience with a wide variety of analytical techniques including HPLC, UV/VIS, CGE, FT-IR and ICE.
  • A BS degree in science, engineering, computer science, or related technical discipline with minimum 2-3 years pharmaceutical/biopharmaceutical experience in a relevant GMP role (validation, quality control, quality assurance, IS/IT compliance, etc.)
  • Past experience working with QC instrumentation in the biopharmaceutical field is preferred but not required.

Our client is a leading Pharmaceutical Organization and we are currently interviewing to fill this and other similar Contract positions. Qualified candidates should apply online for immediate consideration.