Ultimate Staffing is currently sourcing an experienced Lab Manager for our client in the Atlanta, GA area. This role will serve as as technical and administrative responsible of the laboratory, coordinating the people involved in the analytical routine, to comply with the work program previously defined with the Management and to guarantee the quality and control standard in the pharmaceutical products. Ensure the efficiency and effectiveness of the results generated, seeking to maximize the existing resources. Responsible for developing and sending samples to clients.
*Direct Hire Opportunity
*Immediate access to benefits
*Starting as soon as possible
*Salary up to $100K plus additional inventive of 10% of annualized salary upon meeting of company/personal goals
Responsibilities:
Ensure the service to the productive areas, responding to the accuracy and punctuality of the results of process and finished product analysis.
Responsible for interfacing the Quality Control with the other areas involved, acting in the resolution of conflicts and in the increase of the synergy among the people.
Maintain Quality Control in accordance with Safety and 5S procedures.
Responsible for monitoring and achieving Quality Control performance indicators.
Control costs related to the Quality Control Laboratory
Leading and guiding the Quality Control group of people, setting priorities and ensuring the technical resources required for laboratory activities.
Training, guide and evaluate the performance of their subordinates, aiming their professional development.
Properly distribute the tasks and activities of the Quality Control among the subordinates, as well as to manage their functional life.
Calculating adjustments for production batches
Review and approval of contract and internal laboratory results for raw materials and finished products
Record and maintain electronic data base for tracking approved pharmaceutical raw materials
Review and Approve completed pharmaceutical batch documentation prior to shipping.
Maintain due dates of outside calibrations: Operational Qualification and Preventative Maintenance of gas chromatographs and HPLC, balances, standard thermometer, etc.
Development and revision of pharmaceutical Standard Operating Procedures (SOPs)
Perform annual SOP review.
Assist with on-site audits of the pharmaceutical program
Create and revise documentation for the required for all aspects of the pharmaceutical program: batch documentation, raw material testing, product specifications, raw material specification, etc.
Maintain files of pharmaceutical records and documentation
Assist contract laboratory, customers and internal personnel with technical questions
Perform and document annual product review of each pharmaceutical product manufactured
Manage submission of annual active pharmaceutical ingredient testing
Review and approve all documentation used in the pharmaceutical program
Investigate and report on all Non-conformance issues
Investigates and make determination on root cause of any issue concerning manufacturing, laboratory testing, documentation, etc.
Consistently review and determine correction of existing pharmaceutical documentation and make revisions where necessary
Prepare developmental samples for customer evaluation
Perform customer technical support
Draft and implement product process validation protocols and reports
Develop, draft and implement analytical methods and draft method validation protocols
Review and process data associate with protocols and reports on findings
Review developmental and laboratory data to determine best course of action