Quality Specialist

Work Schedule

First Shift (Days)

Environmental Conditions

Office

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.

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.

Education & Experience

Minimum of a Bachelor’s degree, preferably in a scientific field, with relevant experience in pharmaceutical Manufacturing or Quality. At least five years of 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 preferred. 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.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000 colleagues, we share a common set of values – Integrity, Intensity, Innovation and Involvement – working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.

This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.