PDS QC Document Reviewer I

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 I to join our team in Gaithersburg, MD. This position will be primarily responsible for reviewing all laboratory documents, records and logs for accuracy and adherence to analytical plans, methods, SOPs, GLP guidelines, and established laboratory policies. This position is performed under regular supervision.

Salary for range for this position is $21.81- $26.65 per hour. Salary and job title will be commensurate with experience and qualifications. Position is hourly and non-exempt. Smithers PDS offers a comprehensive health insurance package including a choice of 3 medical plans, dental insurance, vision insurance, 401K retirement plan and PTO.

• Reviews analytical plans, method, and SOPs and ensures that run folders, notebooks and other study documentation to identify documentation errors that may result in either potential or actual deviations.
• Keeps detailed documentation of noted QC findings for each document reviewed, clarifying where necessary and/or appropriately communicating findings to PMs, Lab Supervisors, and Analyst as appropriate.
• Effectively communicate with lab personnel or Project Managers to resolve any discrepancies, if applicable.
• Assures that all QC findings and deviations are corrected and/or addressed in a timely manner and consistent with good documentation practices and SOPs.
• Assures that all run folders are ready and available to submit to QA to meet client deadlines.
• Escalates unresolved findings to appropriate supervisor or Project Manager, or higher, when necessary.
• work as a liaison between analysts, study coordinators, and project managers to ensure that all corrections and changes made to assay folders are communicated across groups.
• Other duties as assigned.

• Minimum of a High School Diploma
• Six months to one year experience
• Basic competence using MSOffice (Excel, Outlook, Teams, Word)
• Must be detail oriented, well organized with exceptional communication skills.
• Ability to review documents for long periods of time and recognize errors.

• Knowledge of or previous experience with 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.

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Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)