QA Engineer I Change Management

Work Schedule

Environmental Conditions

Job Description

Location: Grand Island NY Relocation assistance is NOT provided.

*Must be legally authorized to work in the United States withoutsponsorship now or in the future.

*Must be able to pass a comprehensive background check whichincludes a drug screening.

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.

At Thermo Fisher Scientific youll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. Youll play a vital role in enabling our customers to make breakthrough discoveries and innovations. Youll 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:

Education and Experience:

• Minimum Required Education: HS Diploma/ GED and 2 years of relevant QA experience

• Bachelors 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

Knowledge Skills and Abilities:

• 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

What We Offer

Competitive Salary:

• Pay rate based on experience

• Annual performance-based bonus

• Annual merit performance-based increase

Excellent Benefits!

• Medical Dental & Vision benefits-effective Day 1

• Paid Time Off (120 hours per year) Designated Paid Holidays

• 401K Company Match up to 6%

• Tuition Reimbursement eligible after 90 days!

• Employee Referral Bonus

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 100000 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.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

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