Job Description

The main purpose of the Quality Control Manager position is to assure the consistent quality of the MEDISCA products, compliance with regulations (FDA, DEA, cGMPs etc.) and company policies and procedures. *Relocation bonus (moving expenses) will be offered*  The Opportunity: Manage and Support: Equipment, Process and Facility validations Deviation, NCMR investigations and CAPA Environmental monitoring (temperature, humidity and security) requirements for the facility Release of Bulk materials (APIs, non-APIs and devices) and finished goods based on release specifications and test data Maintain physical locations including Quarantine, Reject, Rework, and Return to supplier areas Manage the QC Team Delegate work to the QC Team, ensure compliance with all regulations Oversee Lab Sign-offs and Finished Goods release Approve the release of Bulk materials based on release and test data Monitor calibration-change control and equipment Continuous improvements and employee development and training programs Support Quality Assurance requirements as needed Assure Adherence to Regulations Ensure DEA, FDA and cGMP compliance Support controlled substance operations Evaluate current procedures and apply changes to improve efficiencies Write and review Standard Operating Procedures (SOP’s) Internal and Customer Regulatory Inspections Host all regulatory and customer inspections Responsible Quality Management Provide inspection details to upper management Discuss observations and implement corrective actions * Salary to be discussed

Benefits

• Health Dental Vision Available after 30 days
• Paid vacation
• 401(k) plan

Qualifications

• College degree
• Must pass drug screen

• Minimum of five (5) to seven (7) years in QA/QC/QS
• Previous experience in management
• Knowledge of cGMPs, 21 CFR Part 211 and DEA regulations
• Very good command of Microsoft Office (Word, Excel, Outlook) required
• Excellent communication skills required; fluent English (oral & written)

About Medisca Inc.

Founded in 1989 and headquartered in Montreal, Canada, Medisca is a supplier of pharmacy compounding products that offers service to the North American, Australian and international markets. The Company provides the compounding industry with active pharmaceutical ingredients, including controlled substances; excipients in the form of bases, oils, colours and flavours; and equipment and devices.

Job Tags

Similar Jobs