Quality Assurance Management encompasses a range of duties and responsibilities essential for maintaining high standards of quality and compliance. Key responsibilities include:
- Understanding Regulations: Ensuring familiarity with quality standards and processes to comply with federal, state, and local regulations.
- Effective Communication: Demonstrating strong communication skills for reporting, meetings, and status updates.
- Quality Audits: Conducting thorough quality audits, assessments, and approvals.
- Analytical Skills: Using critical thinking and problem-solving skills to investigate non-conformances and process gaps.
- Metric Monitoring: Maintaining quality metrics through monthly trending and reporting.
- Product Release: Reviewing environmental data, monitoring data, visual inspection data, and label reconciliation to ensure finished goods meet specifications per USP.
- Compliance Assurance: Ensuring products adhere to quality standards for drug product release.
- Non-Conformance Reports: Preparing reports by collecting, analyzing, and summarizing data using DMAIC tools.
- Training and Management: Training and managing QA associates on CAPA, deviations, and OOS investigations.
- Team Collaboration: Working effectively with cross-functional teams.
Essential Duties and Responsibilities
- Audit Responses: Preparing responses to audits, deviations, out-of-specification investigations, and CAPA.
- Vendor Qualification: Ensuring vendors meet qualification standards for material and product supply.
- Quality Systems Management: Participating in the management of Quality Systems, monitoring effectiveness, and providing updates to Senior Quality management.
- SOP Management: Authoring and revising SOPs through review and approval processes.
- Calibration Oversight: Overseeing the calibration and PM program for critical equipment.
- Policy Adherence: Ensuring QA policies and procedures are correctly followed.
- GMP Compliance: Ensuring adherence to GMP procedures and regulations in GMP areas related to ISO standards, cGMP, and industry practices.
- Team Management: Managing the team to ensure timely completion of QA tasks.
- Change Controls: Assisting with submissions of applicable change controls as needed.
- Additional Duties: Performing other tasks as requested by senior management.
Additional Management Tasks
- Performance Indicators: Developing and maintaining key performance indicators for associates to optimize resource capacity.
- Feedback Provision: Providing feedback to senior management regarding capacity constraints.
- Team Performance Monitoring: Developing and monitoring performance measures for effectiveness and efficiency.
- Goal Setting: Setting and achieving individual and team goals aligned with department and site strategies.
- Mentoring: Serving as a mentor and trainer for QA and Operations staff in corrective action, investigation reporting, and GXPs.
Qualifications
- Education: Bachelor’s degree in Science or Engineering (Master’s preferred) plus 5-7 years of relevant experience.
- Regulatory Knowledge: Strong understanding of GXP regulations (21 CFR 210, 211, and 503B).
- Experience: Recent experience with aseptic drug product validation, critical equipment calibration, and bulk manufacturing preferred.
- Skills: Proficient in safety, quality systems, quality assurance concepts, and computer software (Word, PowerPoint, Excel). Ability to work under pressure and meet deadlines with strong critical thinking and ethical standards.
- Knowledge: Extensive knowledge of 21 CFR parts 503B, 210, 211, and other related regulations
