QC Analyst in Lexington, MA at Apex Life Sciences

Date Posted: 9/12/2018

Job Snapshot

Job Description


Description:

Analyze samples using specific procedures and instrumentation. Maintain documentation. Recognize specification ranges. May provide assistance in troubleshooting results outside of predefined specifications.

Job Summary:

  • Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies.
  • Testing may include but not limited to samples from drug substance and drug product manufacturing, stability, raw materials and various protocol studies using test methods derived from the various compendia and non-compendial sources.
  • May assist in sampling activities.
  • This position is expected to maintain operational and GMP readiness of the QC areas.
  • In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with supervision.

Discretion/Latitude:

Work is closely supervised. Follows specific, detailed instructions.

Specific QC Focus Areas:

Product Testing – QC Biochemistry: Area focuses on a broad range of techniques such as separation methods (SDS-PAGE), Potency (enzyme activity), PCR, and compendial methods (UV-Vis spectrophotometry, moisture, pH, and osmolality).

% of Time - Job Function and Description

  • 60% - Testing execution
  • 30% - QC operations support which entails data review, data trending, OE initiatives, maintenance of equipment and reagents, lab housekeeping, support for other QC groups (if necessary)
  • 10% - Compliance and quality systems (SOP revisions, input to quality systems records)

Education and Experience Requirements

Normally requires a bachelor’s degree and a minimum of 0-2 year’s related experience.

(Science related degree is preferred)

Knowledge:

Limited use and/or application of basic principles, theories, and concepts. Limited knowledge of industry practices and standards. Position requires critical thinking.

Key Skills: MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding

Complexity and Problem Solving

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.




885758