QC Reviewer

Work Schedule

Environmental Conditions

Job Description

QC REVIEWER:

Role: QC Reviewer Data Verifier

This is a fully remote role supporting our customers site in King of Prussia PA. We welcome applicants from all locations within the US.
Must be legally authorized to work in the United States withoutsponsorship.
Must be able to pass a comprehensive background check whichincludes a drug screening.

At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.

Within our Analytical Services team we have a functional service provider solution which is a unique partnership that allows our customers to leverage the experience of our staff while allowing you the employee to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company all while maintaining full-time benefits.

Key responsibilities:

• The individual will interact with internal multidisciplinary teams to ensure successful delivery schedules of documents used in the preparation of regulatory filings (IND IMPD MMA BLA and NDA)
• Ensure subject matter experts and relevant parties provide documents required for regulatory submissions and background source information
• Verify data in regulatory submissions matches data in source documents
• Verify data in source documents matches data matches raw data
• Identify gaps where documents are not available or complete
• Communicate any discrepancies with the parties involved and take steps to correct them in a timely manner.
• Performing a check of the current data to ensure that it is accurate consistent and reflects its intended purpose.
• Assesses procedures for accuracy simplicity and practicality and influences changes as appropriate
• Builds and maintains good working relationships with internal and external partners
• Manages issues and risks identified in area of responsibility.
• Evaluates laboratory data for compliance with analytical methods and SOPs.
• Reviews sample results for completeness and accurate representation of the data and report findings.
• Communicates with laboratory staff to proactively address the quality of laboratory documentation.
• Prepares QC statements noting deficiencies with the analytical data set or notebooks. Reports deficiencies to the project leader for correction.

Education and Experience:

• Associate/Bachelors Degree in Science or an engineering discipline
• 2 years of previous experience that provides the knowledge skills and abilities to perform the job OR Masters degree and related experience.

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.

Knowledge Skills and Abilities:

• Understanding and hands on experience of Good Manufacturing Practices and Good Documentation Practices in a pharmaceutical environment.
• Demonstrated proficiency with MS Word Excel PowerPoint.

Working Environment:

• Below is listed the working environment/requirements for this role:
• Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with
• proficiency.
• May have exposure to potentially hazardous elements including infectious agents typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Benefits

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation!