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Quality Assurance Analyst 2
2 months ago
Job Summary: We are seeking a highly skilled Quality Assurance Analyst 2 to join our team at Mindlance. The successful candidate will be responsible for providing daily Quality Assurance support to our manufacturing site to ensure internal and regulatory compliance with cGMP and CFR requirements.
Key Responsibilities:- Quality Assurance Support: Provide daily 'Shop Floor QA support to warehouse, bulk manufacturing, and packaging lines.
- Leadership Support: Provide leadership support to QA Shop Floor activities, including communication of quality events to management.
- Batch Record Review: Perform or support activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases.
- Investigations: Provide support to Investigations and/or Investigation Protocols, including conducting, writing, reviewing, and approvals.
- Line Audits: Perform or support activities related to Line Audits, Line or Area Cleaning Verifications.
- Quality Processes: Participate in the design of quality processes and creation/modification/approval of Standard Operating Procedures (SOPs).
- Consumer Complaints: Provide support to Consumer Complaint investigations.
- Project Support: Provide QA support to various project teams, as needed.
- Site Metrics: Actively support Site metrics, compliance improvement, and training initiatives.
- Qualifications: 3-5 years of Pharmaceutical Industry Quality Experience, with proven success in quality systems/compliance improvement.
- Education: Technical B.S. or B.A. College Degree in Science is preferred.
- Skills: Active cGMP Interpretation and Application Experience, demonstrated leadership, strong organizational skills, strong communication/interpersonal and facilitation skills, problem-solving/investigation experience, expertise in handling multiple priorities, process and systems experience, especially with SOPs, MBRs, Change Controls, Non-Conformance, investigation documentation, and experience with Liquid Dose processing and packaging technology preferred.
