Searchco

Quality Lab Manager

How to Apply for this Job
Company: Searchco Contact Name: David A. Ferris Email your resume (Click Here) Use one of the above methods to apply for this job.

• Job ID:SC18765BRAL
• Date:05/15/2008
• Location:Hoover
• State:Alabama
• Degree:BS

Salary Range:$90,000 to $99,999

This salary range was selected from the ElitePharmacyJobs.com salary data list. See the "Additional Salary" or contact the Recruiter for actual salary and benefits.

Job Types:

Analytical Laboratory, Research & Development

Responsible for all quality related activities performed in the BioLife Hoover Laboratory including Serology, PCR pooling, Anti-D and any additional task the laboratory may take on. Must plan, organize and supervise all activities of the Quality Organization within the Hoover Laboratory to ensure the safety and reliability of BioLife plasma, and to comply with quality and regulatory requirements. Responsible for making critical decisions to release materials and test results in timely manner. Identify potential risks associated with laboratory operations and lead teams to resolve issues. Serve as a contact person for the quality related issues in the laboratory and manage all Quality and Regulatory Inspections. Work closely with Operation's team to ensure effective laboratory operations as well as product safety. Interpret applicable quality and regulatory requirements (e.g., FDA, GLP's/cGMP's, USP, EMEA, CLIA and iQPP regulations, and guidelines), develop policies to implement these requirements for the laboratory operation. Ensure Quality Systems are in compliance with company procedures. Prepare the laboratory for audits by both internal and external authorities. Conduct internal audits to ensure compliance to all relevant procedures. Maintain effective processes for tracking and addressing non-conformances in a timely manner. Ensure compliance with testing procedures and specifications. Monitor the testing techniques and accuracy of all records and documentation that is done in the lab. Ensure all systems, assays and equipment are validated and maintained properly.Manage quality operations budget and head count for the lab. Work with Operations to provide long-term objectives, general policies and management guidance based on business directions and goals. Work with Operations and participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings and improve quality. Maintain appropriate staffing and ensure employees are properly trained. Evaluate performance via performance appraisals. Provide periodic updates to BioLife Sr. Management on the status of the laboratory operations and key metrics as requested.

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