Quality Control Manager jobs in Burlington, VT

Medisca is a global corporation with locations throughout North America, Australia, and Europe, that contributes to healthcare by leveraging strong partnerships that deliver customized solutions with an unwavering commitment to quality and innovation. Backed by 30 years and a strong foundation in pharmaceutical compounding, Medisca is a business-to-business company that delivers comprehensive offerings by providing value, consistency, responsiveness, and loyalty. From pharmaceutical compounding products and services, to supply chain solutions, mixing technology manufacturing, analytical testing, IP licensing, to education services and more – Medisca delivers extensive solutions that leverages a strong network of partners committed to deeply caring about people. As Partners in Wellness, Medisca offers an unfailing devotion to improving lives, across a multitude of needs and across a multitude of people.

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.

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

TRAVEL: Up to two (2) weeks per year to attend seminars, conferences or trainings.

You:

• Minimum of five (5) to seven (7) years in QA/QC/QS
• Previous experience in management
• Bachelor’s degree in a Science related field
• Knowledge of cGMPs, 21 CFR Part 211 and DEA regulations
• Strong planning, organizing and time management skills
• Very good command of Microsoft Office (Word, Excel, Outlook) required
• Excellent communication skills required; fluent English (oral & written)
• Strong leadership and coaching skills
• Ability to think analytically and use good judgement when decision making
• Customer focused, reliable with ability to portray positive & professional image

What’s in it for you…

We invest time and resources into making sure Medisca is as good as the people we hire.

• Balance Your Life – PTO, vacation policy and paid statutory holidays
• Invest in your health – Group Benefit plan and health savings account
• Your Future is Bright – Opportunities to learn and grow within Medisca
• Save for your Future – 401k plan retirement plan
• Help us grow – Employee Referral Program
• We like to have fun – company events throughout the year

#LI-onsite