Aseptic QA Lead — Day Shift (MQA)

Woodstock Sterile Solutions; Woodstock (IL); On-site; USD 80,000 - 95,000; Full time

Job summary

Woodstock Sterile Solutions is seeking an MQA Supervisor to lead day shift quality assurance operations and support the consistent manufacture of safe, compliant sterile pharmaceutical products. This role provides day-to-day leadership for QA Specialists and QA Associates while partnering closely with Operations, Maintenance, MQA Management, customers, and regulatory agencies.

The MQA Supervisor coordinates quality activities across the manufacturing environment, including batch record review,

Qualifications

• Bachelor's degree preferred or equivalent combination of education and relevant work experience.
• Four to six years of relevant experience in the pharmaceutical industry.
• Experience with cGMP and FDA regulations.
• Experience supporting regulatory audits preferred.

Responsibilities

• Lead shift QA operations, including scheduling and work assignments for QA Specialists and QA Associates.
• Provide leadership, direction, coordination, and review of QA team activities in support of manufacturing operations.
• Perform and oversee batch record review, document change control, training, deviation, CAPA, quarantine, and quality-metric activities.
• Investigate, analyze, troubleshoot, resolve, and document quality issues in collaboration with Operations, Maintenance, MQA Management, and customers.
• Initiate, review, and complete quality documentation, including batch records, SOPs, work instructions, quarantines, deviations, validation protocols, customer complaints, and training records.
• Communicate quality issues promptly to MQA and Operations Management and support timely, appropriate decisions related to product quality, compliance, and customer commitments.
• Support customer and regulatory audits and contribute to effective responses and follow-up actions.
• Maintain the effectiveness of quality-system components relevant to the position and drive improvements in quality systems, business systems, and processes.
• Identify, evaluate, and manage product-quality risk; communicate applicable risk policies and processes throughout the organization.
• Develop staff capability, teamwork, flexibility, and individual performance through coaching, training, and daily leadership.

Skills

Leadership

Communication

Multi-tasking

Statistical analysis

Root-cause analysis

Regulatory knowledge

Customer interactions

Documentation

Education

Bachelor of Science degree preferred

Equivalent combination of education and experience

Job description

Woodstock Sterile Solutions is seeking an MQA Supervisor to lead day shift quality assurance operations and support the consistent manufacture of safe, compliant sterile pharmaceutical products. This role provides day-to-day leadership for QA Specialists and QA Associates while partnering closely with Operations, Maintenance, MQA Management, customers, and regulatory agencies.

The MQA Supervisor coordinates quality activities across the manufacturing environment, including batch record review,