The QC Analyst III position is a highly experienced analyst position within the QC laboratory. The QC Analyst III performs testing of any and all samples submitted to the laboratory in a cGMP compliant manner. The QC Analyst III requires the least comprehensive in-house training curriculum of any analyst position in the laboratory by virtue of prior experience, although documented proficiency is required for the execution of all activities. The QC Analyst III performs all activities according to approved written procedures. Because of the level of experience associated with this position, a QC Analyst III may be assigned the responsibility of specialized compliance functions within the laboratory, such as controlled substance management, equipment IQ, OQ, PQ activities, reference standard inventory control, cleaning validation swab procedures, and method validation and transfer activities. The QC Analyst III will be required to write or revise SOPs, analytical procedures, analysis reports, validation documents, etc. at the discretion of quality control supervisory staff.

SKILLS/ABILITIES:

• Ability to perform routine analysis, such as wet chemistry and operate basic laboratory equipment.
• Understands paperwork review process.
• Ability to follow written procedures and exhibit excellent documentation practices.
• Strong analytical techniques in wet chemistry/chromatography
• Practical experience with various types of laboratory instrumentation
• Troubleshooting skills with analytical methodology and instrumentation.
• Strong technical writing skills

EDUCATION AND EXPERIENCE:

• Minimum BS degree in Chemistry or related scientific field
• Approximately 5 years’ laboratory experience in a regulated environment.
  

  LI-RS1

Onsite

• Perform testing in accordance with written procedures for: stability samples, raw materials and packaging components, in-process manufactured material, and finished product (bulk or packaged).
• Documentation of laboratory activities including worksheet/notebook entries according to procedures that define laboratory documentation practices.
• Processing of electronic data using procedures that ensure data integrity and security.
• Ship samples to contract testing facilities.
• Review and approve results of raw material tests from contract laboratories.
• Review and countersign (when necessary) logbooks, notebooks, and worksheets for the purpose of verifying compliance with written procedures, good documentation practices, data integrity and accuracy of calculations.
• Transcribe results onto analysis reports.
• Perform daily standardization and performance verifications on laboratory equipment.
• Comply with site wide procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety, and electronic data security.
• Identify deviations to written procedures. Write deviation investigation reports.
• Disposal of laboratory waste on an as needed basis.
• Identify and report unsafe conditions within the laboratory.
• Perform testing to support method validations, method transfers, process and cleaning validations
• May be called upon by QC management to be responsible for a critical compliance functions within the QC laboratory such as controlled substance steward, reference standard coordinator or trainer.
• Execute equipment qualification protocols.
• Qualify in-house reference standards.
• Write, revise or review SOP’s, analytical protocols, analysis reports, sampling plans, inspection reports, authorized specifications, and controlled forms and worksheets, method validation protocols, and method transfer protocols.
• Write and review equipment qualification documentation.
• Qualify as trainers on test method procedures. Execute and document training. Assist in the creation and implementation of laboratory training programs.
• Troubleshoot problems encountered with existing analytical methodology and instrumentation.
• Comply with DEA regulations and internal controlled substances security and reconciliation procedures.
• Identify OOS results, atypical results, and atypical laboratory events requiring a laboratory investigation. Perform investigative testing and write investigation reports.

Secondary Responsibilities:

• Write SOP’s defining calibration and preventative maintenance procedures.
• Execute and document preventative maintenance and calibration procedures on laboratory equipment.
• Compile data packages for submission to QC management for final review.
• Sample login verification.
• Perform new equipment demonstrations and evaluation.
• Data Security.
• Designated department training coordinator with responsibility for assisting manager with monitoring and tracking department training requirements. Responsibilities will include updating training requirements profiles; circulating and tracking training records; generating gap analysis reports; coordinating department training; and attending department training coordinator update/training sessions. (if applicable)