Quality Specialist

at  Thermo Fisher Scientific

JOB DESCRIPTION

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

SUMMARY:

This role offers an outstanding opportunity to perform Annual Product Reviews (APR)/Product Quality Reviews (PQR) and Continued Process Verification (CPV) for commercially marketed products. You will prepare reports adhering to US GMP and international GMP standards.

EDUCATION & EXPERIENCE

Minimum of a Bachelor’s degree, preferably in a scientific field, with validated experience in pharmaceutical Manufacturing or Quality. Proven experience in Quality Assurance, Quality Control, or in an FDA-regulated industry. Experience performing Annual Product Review/Product Quality Review and/or Continued Process Verification (CPV) is helpful. Technical writing experience is required.

KNOWLEDGE, SKILLS, ABILITIES

• Clear communication with internal and external partners regarding CPV/APR/PQR reports.
• Good critical and logical thinking skills.
• Effective written, interpersonal, and presentation skills.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
• Basic statistics and experience with Minitab is a plus.

ESSENTIAL FUNCTIONS:

• Write, review, and approve APR, PQR, and CPV reports.
• Collect and evaluate data from various resources.
• Clearly communicate results by detailing activities, data, and conclusions.
• Ensure completed reports are sent and coordinate with clients regarding questions or trends.
• Collaborate with resource owners to collect, interpret data, and prepare reports.
• Maintain APR/PQR/CPV files.
• Perform other tasks as assigned.

RESPONSIBILITIES:

• Proven knowledge of cGMP regulations and quality systems.
• Good understanding of manufacturing and quality operations.
• Ability to read and interpret relevant regulations.
• Familiarity with Batch Records and proficiency in LIMS, TrackWise, Discoverant, Microsoft Excel, SAP, and SAS/JMP/MiniTab.
• Ability to interpret raw data and recognize trends or issues.
• Self-starter, able to work independently.
• Influence others to address recommendations in reports.
• Strong written communication abilities.