Supervisor, Quality Assurance

About the role

The Quality Assurance Supervisor will oversee daily workflow of QA activities on the packaging and distribution floor, including in-process audits, line clearance, cleaning verification, and labeling approval. They will train and mentor associates as needed, resolve problems/issues with internal clients, identify continuous improvement opportunities within QA, independently lead improvement and/or other projects within QA, independently author SOPs and forms, effectively utilize problem solving tools (i.e., fishbone, five whys) to lead investigations, communicate effectively with both internal and external customers, peers and management to facilitate the smooth and timely completion of projects, conduct packaging audits (on-the-floor), and identify and report cGMP or SOP compliance issues as necessary.

Responsibilities

• Oversee daily workflow of QA activities on the packaging and distribution floor, including but not limited to: in-process audits, line clearance, cleaning verification, and labeling approval
• Train and mentor associates as needed
• Resolve problems/issues with internal clients
• Identify continuous improvement opportunities within QA
• Independently lead improvement and/or other projects within QA
• Independently author SOPs and forms
• Effectively utilize problem solving tools (i.e., fishbone, five whys) to lead investigations
• Communicate effectively with both internal and external customers, peers and management to facilitate the smooth and timely completion of projects
• Conduct packaging audits (on-the-floor)
• Identify and report cGMP or SOP compliance issues as necessary

Requirements

• Minimum 3 years of experience in a Quality Assurance role in a GxP facility
• Strong knowledge of cGMPs and ability to ensure compliance with SOPs and regulatory requirements
• Experience supporting QA activities on a manufacturing/packaging floor (e.g., audits, line clearance, in-process checks)
• Experience leading or supporting deviations, investigations, and root cause analysis (e.g., fishbone, five whys)
• Ability to work cross-functionally and resolve issues with internal stakeholders
• Strong communication skills with internal and external customers
• Ability to manage multiple priorities and work effectively under pressure to meet deadlines
• Strong organizational skills and ability to handle multiple activities simultaneously

Qualifications

• Education: Bachelor's degree in a related field (e.g., Quality Assurance, Engineering, Science)
• Experience: Minimum 3 years of experience in a Quality Assurance role in a GxP facility

Skills

• Knowledge of cGMPs and ability to ensure compliance with SOPs and regulatory requirements
• Experience supporting QA activities on a manufacturing/packaging floor (e.g., audits, line clearance, in-process checks)
• Experience leading or supporting deviations, investigations, and root cause analysis (e.g., fishbone, five whys)
• Ability to work cross-functionally and resolve issues with internal stakeholders
• Strong communication skills with internal and external customers
• Ability to manage multiple priorities and work effectively under pressure to meet deadlines
• Strong organizational skills and ability to handle multiple activities simultaneously

Benefits

Catalent offers competitive medical benefits and a 401K plan. Employees also receive 152 hours of PTO plus 8 Paid Holidays. The company provides a dynamic, fast-paced work environment and opportunities to work on Continuous Improvement Processes.

Pay

Competitive compensation package based on experience and qualifications.

Schedule

Shift: Monday – Friday 8:00am – 4:30pm