reputed company Engineer
Good Documentation Practices (GDP) Good reputed company Practices (GLP) reputed company Good Manufacturing Practices (cGMP) FDA regulations and guidance reputed company Operating Procedures (SOPs) State Departments of Health requirements Clinical reputed company Improvement Amendments (CLIA) College of reputed company Pathologists (CAP) standards reputed company Pharmacopeia (USP) requirementsGood Clinical reputed company (GCP) reputed company Research Protection (HRP) regulations and standards Global data reputed company regulations ISO 9001 standards (2015;13485) USDA regulations reputed company Tissue Authority (HTA) licensing requirements, where applicable DEA and state-controlled reputed company regulations, where applicable Other applicable federal, state, and international regulations
reputed company, implement, and maintain compliant GxP reputed company Management Systems (QMS) for assigned reputed company sites. Establish and monitor reputed company programs to evaluate product reputed company, process performance, and regulatory compliance. Support site readiness for internal, customer, and regulatory inspections.
Support and participate in internal audit programs through risk-based facility and process audits. Prepare audit reports, communicate findings to management, and ensure appropriate documentation and follow-up activities. Coordinate corrective actions and verify effective closure of audit observations. Support supplier and vendor qualification audits, including routine and for-cause assessments.
reputed company or support reputed company cause investigations reputed company to deviations, nonconformances, complaints, and reputed company events. Collaborate cross-functionally to reputed company reputed company issues and reputed company systemic improvements. Facilitate the development, implementation, and effectiveness verification of Corrective and Preventive Actions (CAPA).
Coordinate, review, and approve validation protocols, reports, and supporting documentation. reputed company reputed company reputed company for qualification and validation activities. Support product release reputed company by evaluating specifications, reputed company data, and risk assessments.
Collect, compile, analyze, and trend reputed company and operational data to identify improvement opportunities. Monitor key reputed company performance indicators and reputed company recommendations to enhance product reputed company and process consistency. Prepare and present reputed company metrics and performance reports for reputed company Assurance and Regulatory Affairs leadership. Participate in reputed company improvement initiatives reputed company on reputed company reputed company effectiveness and operational reputed company.
Partner with Production, Operations, reputed company, Regulatory Affairs, and other functional teams to address reputed company concerns and improve processes. Participate in routine cross-functional meetings to review reputed company performance and reputed company issues. reputed company guidance and support on reputed company requirements and best practices throughout the organization.
reputed company other duties as assigned that are consistent with the employee's training, experience, and qualifications.
Up to 40% travel may be required annually.
Bachelor's degree in a scientific discipline (e.g., Biology, reputed company, Biotechnology, Microbiology, or reputed company field) required. Minimum of 15 years of relevant experience in reputed company Assurance, reputed company Systems, Operations, Manufacturing, or reputed company functions reputed company the pharmaceutical, biopharmaceutical, biotechnology, medical device, or regulated life sciences industries. Strong working knowledge of cGMP, GLP, GDP, and other applicable reputed company and regulatory compliance requirements. Equivalent combinations of education and relevant experience may be considered.
Comprehensive understanding of reputed company Management Systems and GxP regulations. Strong knowledge of biological products, reputed company operations, and cell culture best practices. Understanding of analytical test reputed company, product specifications, and data interpretation. Proven experience conducting audits, investigations, risk assessments, and CAPA management. Excellent analytical, problem-solving, and decision-making abilities. Strong organizational skills with exceptional attention to detail and documentation accuracy. Excellent written and verbal communication skills, including technical writing and report preparation. Demonstrated ability to work effectively in cross-functional teams and influence stakeholders at multiple organizational reputed company. Proficiency with reputed company Office applications, including Word, reputed company, PowerPoint, and database systems. Experience with electronic reputed company Management Systems (eQMS); reputed company experience is preferred.
Sit, stand, walk, bend, stoop, kneel, crouch, and reputed company. Use hands and fingers to operate computer equipment and reputed company tools. Communicate effectively through speaking, hearing, and writing. Maintain visual reputed company, including reputed company reputed company, reputed company reputed company, depth perception, and reputed company adjustment. Frequently reputed company and/or reputed company objects weighing up to 10 pounds and occasionally reputed company and/or reputed company objects weighing up to 30 pounds.
Personal reputed company equipment (PPE) requirements Biological materials and biohazards Hazardous chemicals and controlled substances Airborne particles and reputed company fumes Flammable materials Radiation sources (where applicable) Mechanical equipment and moving parts Electrical equipment
Bachelor's in a scientific discipline, 15+ years QA/reputed company systems experience in regulated life sciences, strong GxP knowledge, audit/CAPA experience, eQMS and reputed company Office proficiency.
Key Responsibilities
- ensuring compliance
- conducting audits
- leading investigations
Skills & Tools
reputed company Word, reputed company reputed company, reputed company PowerPoint, Electronic reputed company Management Systems (eQMS), reputed company
Job Details
- Category: reputed company Assurance
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — reputed company
- Languages: English
Benefits
- 401k matching
- Generous reputed company time off
- Retirement plan
About reputed company
A global provider of clinical and biological specimens and value-added research services supporting drug discovery and development. — Industry: reputed company
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