QA Engineer I - Change Management

Thermo Fisher Scientific•Grand Island, NY

20h•$48,400 - $70,000•Onsite

About The Position

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. At Thermo Fisher Scientific, you'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. You'll play a vital role in enabling our customers to make breakthrough discoveries and innovations. You'll ensure product quality, drive continuous improvement initiatives, and collaborate with cross-functional teams to maintain the highest standards of quality and compliance in a GMP environment. Key Objectives of the Role: The key responsibilities of this role will include, draft, review, and finalize Change Notifications with customers for multiple BCD sites. Actively support and handle change management and notification activities relating to the Grand Island and BCD business processes. Address complex quality issues directly with customers and support issue resolution. Assist in the creation and modification of processes and procedures to ensure their efficiency. Participate in multi-functional projects of moderate scope to support the BCD Quality Management System. Drive continuous improvement initiatives to ensure the effective implementation of the QMS. Ensure the BCD Quality Management System maintains consistent product quality and regulatory compliance.

Requirements

Minimum Required Education: HS Diploma/ GED and 2+ years of relevant QA experience
Bachelor's degree preferred in Chemistry, Biology, Biotechnology, Engineering, or related scientific/technical field
Experience in pharmaceutical, medical device or regulated industry preferred
Additional certifications in Quality Systems or GMP preferred
Experience with quality systems and documentation including batch records, SOPs, deviations, CAPA
Proficiency in quality management software systems (TrackWise, SAP, etc.)
Experience conducting internal quality audits and supporting external regulatory audits
Experience with continuous improvement methodologies (Lean, Six Sigma) preferred
Demonstrated ability to perform detailed documentation review and quality assessments
Strong analytical and problem-solving skills for quality investigations and root cause analysis
Strong knowledge of cGMP, ISO standards (13485/9001), and international regulatory requirements
Excellent written and verbal communication skills
Ability to work independently and collaborate effectively with cross-functional teams
Proficient computer skills including Microsoft Office applications
Strong attention to detail and commitment to accuracy
Ability to prioritize and adapt in a changing environment
May require up to 10% travel
Must be able to work in controlled environments wearing required PPE

Nice To Haves

Bachelor's degree preferred in Chemistry, Biology, Biotechnology, Engineering, or related scientific/technical field
Experience in pharmaceutical, medical device or regulated industry preferred
Additional certifications in Quality Systems or GMP preferred
Experience with continuous improvement methodologies (Lean, Six Sigma) preferred

Responsibilities

Draft, review, and finalize Change Notifications with customers for multiple BCD sites.
Actively support and handle change management and notification activities relating to the Grand Island and BCD business processes.
Address complex quality issues directly with customers and support issue resolution.
Assist in the creation and modification of processes and procedures to ensure their efficiency.
Participate in multi-functional projects of moderate scope to support the BCD Quality Management System.
Drive continuous improvement initiatives to ensure the effective implementation of the QMS.
Ensure the BCD Quality Management System maintains consistent product quality and regulatory compliance.