- Works within defined policies and procedures.
- Establishes and communicates expectations to team members and monitors performance. Addresses inadequate performance through training, coaching, and other available methods.
- Provides guidance and instruction to team members when needed.
- Assists with conducting interviews and making recommendations for hiring.
- Establishes and monitors performance criteria. Provides routine feedback to team members on performance.Evaluates performance and makes appropriate recommendations.
- Ensures assignments and processes support business aligned goals.
- Solves problems or guides team members to appropriate resource(s) to solve problems and helps to remove roadblocks for team members.
- Generate and review appropriate SOPs and PDS processes.
- Ensures compliance with SOPs and other laboratory policies (safety, security, personnel, etc.).
- Promotes continuous quality improvement initiatives in all operations.
- Reviews all work and ensure performance in accordance with established safety procedures, Company policies, and GLP standards.
- Maintain all appropriate paperwork, and record keeping, including daily logs, timesheet, routine, and non-routine maintenance records.
- Responsible for all instrument service contracts and organize preventive maintenance visits as appropriate.
- Works with Project Management Team on specific sample needs, sample discrepancy resolution and prioritizing work as needed.
- Ensures all raw data is properly documented and maintained and projects are conducted in accordance with the applicable client and/or SOP's and within GLP guidelines.
- Ensures required laboratory support functions are performed according to Standard Operating Procedures.
- Assigns and/or performs Lab Support tasks and responsibilities, including but not limited to:
- Shipment receipt, ensuring shipments are routed to proper places within the building.
- Inspections of facilities and equipment.
- Preventive maintenance tasks.
- Pipet and analytical balance calibrations performed site-wide on routine basis using external contractor or other calibration method.
- As required, set up Watson study designs based on a good understanding of various pharmaceutical studies and their designs and PDS SOPs and plans.
- Reagent inventory and tracking are completed and performed per SOP and PDS processes.
- Interact with Quality Assurance and other functional teams.
- Perform work in an environment requiring rapid turn-around times and high levels of versatility.
- Perform other duties as assigned.
- Perform back-up Archivist responsibilities as needed.
- Knowledge of FDA and other regulatory guidelines for pharmacokinetic and ADA assays
- Ability to prioritize and efficiently manage workload in a fast-paced environment.
- Ability to accurately interpret and communicate organizational information with internal and external clients.
- Ability to effectively interact with clients and regulatory personnel.
- Must be pro-active, highly accountable and detail oriented.
- Ability to consistently and accurately follow SOPs, processes, complete required documentation, and 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).
- High School diploma and 3 plus years' prior relevant experience.
- A minimum of 2 years' experience providing guidance, training, and direct supervision of team members.
- Experienced with specialized laboratory software such as Watson LIMS or other integrated data systems
- Attention to details
- Organized
- Proficient with basic computer applications such as Microsoft Outlook, Word, and Excel
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Supervisor I - Gaithersburg, United States - Smithers
Description
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 Supervisor I or Associate Supervisor. This position will provide daily oversight to lab support operations in Gaithersburg, MD and Ewing, NJ. This position is on-site in Gaithersburg and is expected to spend adequate time in both the laboratory and the office.Will supervise a work group of two or more full-time employees, assign tasks, review assignments regularly, and monitor performance. A portion of the time is normally spent performing individual tasks related to the unit.Has accountability for safety of the immediate work area and direct reports.
The Laboratory Support Team is responsible for critical operational support functions.These functions include, but are not limited to, ensuring necessary reagents are inventoried and maintained; monitoring, performing, and/or managing necessary equipment maintenance; and handling critical reagents and samples.
Primary Responsibilities:
This position may require occasional travel, less than 5%.
Education and Experience Requirements:
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 c)
