Smithers PDS LLC (Pharmaceutical Development Services) assists in the development of new medicines by providing bioanalytical services for all phases of drug development from discovery through approval and post market surveillance. PDS works with customers to develop new methods, validate existing methods, and perform the assays necessary to analyze samples from patients on more than 100 clinical trials. PDS is seeking a Quality Control and Study Coordination Lead. This role is responsible for supervising QC/SC staff through workload management for team members, rent phases of the FDA regulated drug approval process. 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:

• Responsible for ensuring QC/SC staff is adequately trained and performs QC/SC duties as assigned.
• Responsible for scheduling/prioritizing and assigning QC/SC tasks to team members to ensure deadlines are met.
• Complete comprehension and understanding of the client study protocol design.
• Identifying issues and deviations which affect the quality of study-related data and communicating these to the Project Manager or appropriate department manager,
• Communicating with clients and delivering data releases and/or reports, and authoring and/or QC of analytical plans and reports, Watson and Excel data retrieval.
• Independently create Analytical Plans and Reports to support Validation and Sample Analysis etc.
• Tracks and monitors study time-lines and key dates to coordinate resources required to produce deliverables on time. Ensures issues impacting time-lines and key dates are promptly communicated to the Project Manager, Manager, and other key individuals necessary to address
• Assure that all run folders, data tables and reports are moved through QA in sufficient time to meet client expectations. Maintain the flow of run folder reviews through QC and QA.
• Assure that all QC and QA findings are responded to in a timely fashion and are complete and accurate.
• Drive the process related to report finalization with clients.
• Participate in developing and executing process improvement initiatives.
• Keep detailed documentation of noted QC findings for each document reviewed and manage the.
• 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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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)