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Quality Assurance Specialist in Manufacturing Operations
2 months ago
Overview:
Position Summary:
This specialist role is essential for ensuring Quality oversight within manufacturing processes at the facility, monitoring adherence to established protocols and regulatory standards.
Collaborating within a cross-functional team, the specialist will engage with subject matter experts to address Quality concerns and implement enhancements for both new and existing clients, serving as the primary Quality Assurance contact for clients.
Responsibilities include reviewing and approving manufacturing batch records, non-conformances, deviations, and Corrective and Preventive Actions (CAPAs) in alignment with current Good Manufacturing Practices (cGMP). Additionally, the specialist will prepare Certificates of Analysis for batch release.Key Responsibilities:
Review and authorize low-risk non-conforming events (NCE), deviations, and CAPAs. Evaluate and approve pre-executed batch records for designated clients.
Review and validate executed manufacturing batch records.
Prepare manufacturing release checklists and Certificates of Analysis.
Maintain up-to-date knowledge of changes in Good Practice (GXP) regulations, including those from the FDA, EU, and other regulatory authorities, as well as relevant guidance documents (e.g., ICH, ISPE).
Collaborate with project teams to ensure that project requirements are clearly understood and accurately reflected in manufacturing records.
Work alongside QA batch record reviewers to communicate project specifications and ensure that details are properly incorporated into manufacturing documentation.
Compile and review raw data, batch records, and test results, including Final Reports and Certificates of Analysis, in compliance with cGMP, Code of Federal Regulations (CFR), and internal procedures, ensuring efficiency and timeliness.
Revise Standard Operating Procedures (SOPs) as needed.
Review and approve document change requests.
Participate in quality and process improvement initiatives, as well as project teams.
Coordinate the execution of Manufacturing Suite inspections.
Support internal audits, client audits, supplier audits, and regulatory inspections as required.
Act as a contact for on-site client visits.
May be required to work during holidays and weekends.
Contribute to the overall operations and achievement of departmental objectives.
Perform job-specific tasks in compliance with applicable regulations, international standards, and WuXi AppTec policies and procedures.
Demonstrate a thorough understanding of Good Manufacturing Practices.
Other duties as assigned.
Potential for selection for Visual Inspection Qualification, which requires inspecting final products in a light booth to identify defects and record inspection results.
Qualifications:
Experience:
- Minimum of 5 years of relevant experience or equivalent.
Knowledge / Skills / Abilities:
Familiarity with cGMP requirements.
Proficient in Root Cause Analysis techniques.
Extensive experience in writing and/or reviewing and approving Laboratory Investigations, Deviations, and CAPAs is preferred.
Ability to perform duties using appropriate computer software (Microsoft Word, Excel, and Access).
Judgment skills appropriate to the complexity of situations.
Ability to understand and follow verbal or demonstrated instructions.
Effective teamwork and interpersonal skills.
Ability to receive, comprehend, and communicate detailed information effectively in both verbal and written forms.
Physical Requirements:
Ability to work in an office environment with minimal noise.
Ability to work in a laboratory setting with biohazards and various chemicals.
Must be able to wear appropriate personal protective equipment (PPE).
Ability to work in environments with variable noise levels.
Capability to stand, sit, or walk for extended periods.
Clarity of vision and ability to identify and distinguish colors.
Must be able to perform repetitive motion activities.
Ability to climb ladders, stairs, and scaffolding.
Ability to work in varying temperatures, from high to freezing.
Ability to work in both indoor and outdoor conditions.
If selected for visual inspection qualification, the employee must pass an eye exam, including corrected or uncorrected 20/20 vision, a color blindness test, and a depth perception test.
Our Values:
Integrity & Dedication, Collaboration & Shared Success; Upholding Ethical Standards and Excellence.
Our most valuable asset is our people. WuXi is committed to fostering internal growth opportunities with direct access to a dedicated Human Resources team.
