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Full job description
Job Description
Job Description
We are seeking a highly skilled and meticulous professional to join as Sr. QA Technician. When you’re part of the team at Thermo Fisher Scientific, you will be surrounded by collaborative colleagues where you’ll discover meaningful work with equal opportunities that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day!
This position will be responsible for ensuring our products meet the highest quality and reliability standards. This position necessitates a keen attention to detail, exceptional problem-solving skills, and a thorough understanding of processes and methodologies. This position is expected to collaborate and work in partnership to implement quality control measures, identify scope for improvement and drive continuous improvement initiatives throughout the organization.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, growing efficiency in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team of more than 100,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
Responsibilities:
- Conduct inspections and review batch production and analytical records as per the defined procedures for release.
- Maintain comprehensive records & documentation. Manage physical records storage & Location mapping.
- Coordinate Supplier Questionnaires & Qualification of vendor /supplier
- Assist and manage in establishing Standard Operating Procedures (SOP). Assist in routine maintenance of SOPs, including periodic reviews.
- Effectively communicate and follow up on QMS Records with process Owner.
- Implement QA procedures and guidelines and assist in maintaining compliance status to standards and regulations.
- Coordinate to identity & call out potential quality issues.
- Participate in root cause analysis investigations and support for effective implementation of CAPA.
- Assist in training programs & assist maintaining training records as necessary.
- Process Waiver release requests, Lot hold queries from the Distribution center as required.
Qualifications:
- Master`s degree in a life science or related fields with 1- 2 years of relevant industrial experience (Pharmaceutical or cGMP experience preferred)
- Familiarity with compliance & regulatory standards
- Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Monitors own work to ensure quality
- Exhibits sound and accurate judgment
- Demonstrates persistence and overcomes obstacles
- Procedure oriented, responds to management direction; Takes ownership for own actions; Keeps commitments; Completes tasks on time
- Attention to detail and a dedication to delivering high-quality results
- Strong communication expertise (written & verbal).
- Ability to work independently and in partnership in a fast-paced and dynamic environment.
- Strong interpersonal and time management skills to prioritize and complete tasks.
