Overview
Quality Control Technician, II Jobs in Minnetonka, MN at Medvacon Life Sciences
Position Title: Quality Control Laboratory Manager
Reports to: Director of Quality
Direct Reports: Quality Control Chemists, Quality Control Microbiologists, Quality Control Technicians
Basic Function: Supervise laboratory personnel and maintain the Quality Control Laboratory to ensure all products and procedures meet the requirements of 21CFR210, 21CFR211, Regulatory Agencies, and Customer Expectations
Principal Duties:
Maintain the laboratory quality management system to ensure compliance with cGMP.
Establish product test methods and specifications. This includes raw materials, in-process product, finished products and stability samples.
Audit the Quality Control Laboratory to ensure compliance to SOPs.
Investigate, assess, and troubleshoot test and/or equipment problems.
Review Out-of-trend/Out-of-specification results and participate in investigations to determine root cause and CAPA.
Maintain appropriate laboratory inventory to ensure timely release of materials.
Participate in method qualifications, validations, and transfers.
Maintain sample tracking and integrity at all times until analyses are reviewed.
Ensure analytical equipment is calibrated and well maintained at all times.
Ensure that laboratory personnel training requirements are met and that training records are current.
Knowledge and Skill Requirements:
BS in Chemistry, Biology or a related discipline.
Knowledge and control of analytical equipment including calibration and maintenance.
Knowledge of computer software, including relevant applications such as Microsoft Office.
Knowledge of CGMPs regulations.
Understanding of quality systems including change control, deviations and CAPAs.
Ability to handle multiple tasks concurrently and complete tasks in a timely manner.
Strong written and verbal language skills to effectively read and write SOPs and related lab reports and communicate with personnel at all levels in the organization.
Salary: DOE
Job Type: Full-time
Pay: From $100,000.00 per year
Benefits:
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance
Schedule:
8 hour shift
Monday to Friday
Weekends as needed
Experience:
Labatory Manager: 10 years (Required)
Language:
English (Required)
Work Location: In person
Title: Quality Control Technician, II
Company: Medvacon Life Sciences
Location: Minnetonka, MN
