Technical Reviewer

Agawam, Massachusetts, United States Full-time

Position Title: Associate Tech Reviewer (3 positions – Micro, Analytical, & CRS)
Job Location(s): Agawam, MA
Start Date: ASAP
Employment Type: Full-Time
Starting Salary Range: Competitive
Job Requisition #: 18081

Cambrex (www.Cambrex.com) is seeking a highly motivated, energetic, results-oriented individual to join our team of dedicated professionals focused on customer service and quality. We are currently accepting resumes.


DUTIES:

The Associate Technical Reviewer will work with management and other reviewers to provide a technical review for laboratory testing data in compliance with cGMP standards and FDA/ISO regulations.  This position specializes in various aspects of technical data and documentation evaluation and review, laboratory investigations, and a variety of routine and non-routine laboratory tasks.

  • Primarily responsible for performing a technical review of all test results and data for completeness, accuracy and compliance.
    • Scope: All analytical and/or microbiological GxP testing performed on starting materials, raw materials, intermediates, drug substance, drug product, medical devices, packaging components, customer samples, environmental monitoring samples, stability study samples, in-process testing/checks, etc.
    • Method: Ensure all testing was performed per approved SOPs/methods/protocols and comply with specifications by critically analyzing the reported data and results for accurate interpretation and conclusion. Ensure all issues/documentation is complete prior to approval.
    • Timeline: Provides accurate and timely delivery of data review and report any findings to the appropriate departments to support overall project due dates.
  • Assist in laboratory Investigations:
    • Scope: Out of specification (OOS) and aberrant result laboratory investigations.
    • Method: Work with analyst and laboratory management to conduct and document the laboratory investigations. Write testing plans associated with investigations.  Ensure accuracy and compliance of the final investigation results and reports.  Submit final report to laboratory management and QA for approval.
    • Timeline: Ensure timely closure of the laboratory investigation as required by procedure. Escalate issues which may impact timeline to laboratory and quality management.
  • Other tasks may include:
    • Review technical documents such as protocols and technical reports for qualification/validation and stability activities.
    • Review specifications.
    • Review data generated by contract laboratories.
    • Perform routine compendia update reviews to ensure timely revision of test methods.
    • Generate new and/or revise procedures to ensure compliance and adherence to regulated laboratory activities for GMP operations.
    • Assist in tracking and trending laboratory related Quality metrics (KPIs) and designing action plans to address trends.
    • Support regulatory and customer audit through data gathering and serving as an SME for technical questions.
    • All other duties as assigned.


QUALIFICATIONS:

  • BA/BS in a life science with 2+ years of related experience or equivalent
  • Experience working with LIMS and Empower preferred.
  • Demonstrated leadership skills.
  • Demonstrated ability to think critically and to focus on details of execution.
  • Demonstrates ability to work effectively on problems of a diverse scope and with analysis/evaluation of data.
  • Expertise with respect to demonstrating theoretical understanding and providing effective evaluation of laboratory practices such as raw material, drug substance, drug product and medical device testing, compendia methods (e.g. USP/NF, EP, JP), method validation/qualification/transfer, environmental monitoring and clean room environments.
  • Working knowledge of Microbial Limits Testing and identification procedures and/or other microbiology methods, and proficiency in most of these techniques may be required.
  • Experience in trending analytical data (method data and product data) is preferred.
  • Experience in trending environmental monitoring/clean room services data is preferred.
  • Experience in participating and supporting regulatory inspections through explanations of methodologies, investigations, and/or laboratory systems is preferred.
  • Good technical writing skills. Experience authoring and reviewing technical documents such as reports and protocols.

 

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.