Smithers PDS LLC (Pharmaceutical Development Services) brings new drugs to market by providing pre-clinical and clinical services for all phases of drug development. PDS works with customers to develop new methods, validate existing methods, as well as performing the assays necessary to analyze samples from patients on more than 100 clinical trials currently in different phases of the FDA regulated drug approval process. Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories.

PDS is seeking a QC Document Reviewer to join our team in Gaithersburg, MD. The QC Document Reviewer is primarily responsible for ensuring laboratory documents, records and logs are adequately reviewed for accuracy and adherence to SOPs, GLP guidelines, and established laboratory policies.

Corporate Responsibilities:

• Adherence to laboratory health and safety

• Adherence to Standard Operating Procedures (SOPs)

• Adherence to applicable company policies and guidelines

• Adherence to federal and/or local regulations as applicable

Primary Responsibilities:

This position will be primarily responsible for ensuring laboratory documents, records and logs are adequately reviewed for accuracy and adherence to SOPs, GLP guidelines, and established laboratory policies.

• Participate in developing and executing process improvement initiatives.

• Keep detailed documentation of noted QC findings for each document reviewed.

• Assure that all QC findings and deviations are corrected and/or addressed in a timely manner and consistent with good documentation practices and SOPs.

• Assure that all run folders move through the internal process including QAU in sufficient time to meet client timelines.

• Work as a liaison between support groups as assigned.

• Strong organizational skills.

• Effectively communicate with lab personnel or Project Managers to resolve any discrepancies, if applicable.

• Other duties as assigned.

Additional Requirements:

• Knowledge of GLP.

• Ability to multi-task and participate in multiple studies concurrently.

• Ability to produce high quality data while working under the pressure of strict deadlines.

• Overtime and weekend work as required.

• Work may require the use of PPE (personal protective equipment).

Professional Responsibilities: (if applicable)

• Attend continuing education courses, as appropriate.

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