Clinical Operations

  • location: Lexington, MA
  • type: Contract
  • salary: $35.49 - $41.75 per hour

description

Chat with me now! - https://flashrecruit.com/jobs/296765

QC Analyst

Job Responsibilities

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.
  • Work is closely supervised.
  • Follows specific, detailed instructions.
  • Contributions are usually limited to task-related activities. Errors do not typically have a major effect on the organization.
  • 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).

60% of Responsibilities

  • Testing execution

30% of Responsibilities

  • 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% of Responsibilities

  • Compliance and quality systems (SOP revisions, input to quality systems records)

Education & Qualifications

  • Normally requires a bachelor's degree and a minimum of 1-2 year's related experience. (Science related degree is preferred) **must have at least 1 year of experience
  • Limited use and/or application of basic principles, theories, and concepts. Limited knowledge of industry practices and standards.
  • Position requires critical thinking.
  • MS Office, LIMS, SAP, Trackwise, EDMS, compliance and strong science understanding
  • Solve routine problems of limited scope and complexity following established policies and procedures.
  • Works on problems of limited scope.
  • Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
  • Builds stable working relationships internally.

Benefits

  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

Chat with me now! - https://flashrecruit.com/jobs/296765

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