Sr. QA Specialist

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

How Will You Make an Impact

The Senior Quality Specialist Project Lead at Thermo Fisher Scientific plays a crucial role in providing technical leadership and Quality oversight for a Sterile Manufacturing Environment ensuring compliance with pharmaceutical regulations. This positionis responsible formaintainingfull company compliance to prevent regulatory actions that could hinder product quality lead to stoppages or impact customer satisfaction.

A Day in the Life

• Leadsprojects of moderate complexity conducting compliance assessments making decisions on regulatory requirements drafting new procedures and ensuring adherence to current regulations.

• Oversees the quality of methods processes materials and products by coordinating and reviewing group operations providing staff training and assessing/improving systems and processes.

• Responsible for reviewing and approving procedures training documents forms deviation and change control of moderate to high complexity.

• Performs risk assessments and takesappropriate actionsto ensure adequate controls related to product quality safety and business risks.

• Act as a technical resource for system support and new product introduction by interpreting regulatory requirements andestablishingsystems.

• Makesdecisions on compliance issues within facilities equipment manufacturing and support areas considering the level of risks related to compliance and product quality.

Education

• Bachelordegreerequired preferably in technology engineering scientificfieldor relatedarea.

Experience

• Minimum5 years of experience in Quality Assurance Quality Control or Operations/Manufacturingrequired.

• Equivalent combinations oftrainingand meaningful work experience may be considered if at least abachelordegree isacquired.

Knowledge Skills Abilities

• Project managementexpertise

• Strong knowledge of regulatory requirements and quality standards

• Excellent interpersonal and leadership abilities attention to detail organizational skills effective communication skills negotiation skills and understanding of quality systems and technical writing.

• Professional certifications (e.g. CQA) and training in Six Sigma are beneficial.

• Demonstrated commitment to fundamental principles of Integrity Respect and Excellence is essential.

• Abilityto work independently and to remain firm in complex situations isrequiredin this fast-paced environment.

Physical Requirements/ Work Environment

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand walk stoop kneel crouch periodically for prolonged periods of time; manipulation (lift carry move) of light to medium weights of 10-35 pounds; arm hand and finger dexterity including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard computer monitor operate equipment and read materials for prolonged periods of time; ability to sit reach with hands and arms talk and hear for prolonged periods of time.