|Director of Quality Control
|VP and GM of Operations
|The Head of Quality Control will be an instrumental part in the re-opening of our Manufacturing facility in Decatur, Illinois. This individual will be responsible for building a new QC team and a GLP compliant Quality control lab for the site. This position will also be responsible for developing QC systems and practices, maintaining cGMP Compliance, managing, and being prepared for FDA inspections, developing laboratory training programs, and other important functions listed below.
|Essential Duties & Responsibilities:
|• Responsible for building a new Quality Control team and establishing a GLP compliant Quality Control lab for a commercial manufacturing site. This includes analytical, microbial, technical services, stability, and sample management groups for sterile pharmaceutical products
|• Provide direction for analytical, microbial, technical services and sample management groups to ensure timely testing
|• Ensure Laboratory Equipment and Utility Qualifications, Appropriate qualification/validation of analytical methods and transfer and validation of methods between manufacturing sites
|• Ensures that QC Systems and practices are developed and implemented in accordance with the requirements of cGMP
|• Establishes and publishes Key Performance Indicators to track cGMP compliance for the Quality Control function
|• Works with senior stakeholders, develops plans and strategic direction for the team
|• Collaborate with FDA as the need arises representing the firm to authorities and regulatory inspectorates in matters relating to GMP
|• Supports standardization and harmonization of Standard Operating Procedures
|• Participate in inspections and audits of the laboratories
|• Direction of QC functional groups to ensure timely testing
|• Oversight of laboratory training programs
|• Responsible for conducting laboratory investigations, OOS, OOT
|• Generation of CoAs for product release
|• Draft analytical and stability sections of regulatory submissions
|• Monitor and trend data while assembling reports on product release test monitoring of company cGMP facility
|• Frequently update stakeholders on trends
|• Implement corrective action plans
|• Tracking of data from external contract laboratories to complete lot disposition
|• Establish user requirements for purchase, qualification of QC analytical equipment
|• Work with internal and external resources to maintain equipment in an efficient state
|• Develop, revise and review SOPs, qualification/validation protocols and reports
|• Monitor the GMP systems currently in place to ensure compliance with documented policies
|• 10-12 years’ experience of Quality Control experience in Pharmaceutical or Biopharmaceutical space
|Specialized Training or Technical Knowledge Licenses, Certifications Needed:
|• Working knowledge of MS Word, Excel, Outlook, and Power Point
|• Working knowledge of Adobe Acrobat
|• Excellent conceptualizing, analytical and problem-solving skills
|• Effective written and oral communication skills
|• Strong organizational, planning and communication skills.
|• Demonstrates exceptional time management skills.
|• Using logic and reasoning to identify solutions to problems.
|• Ability to multi-task, set priorities and meet strict deadlines.
|• Ability to lead, motivate, coach, and teach others