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Thermo Fisher Scientific · 1 day ago

QA Engineer I - Change Management

Grand Island, NY

Full-time

Onsite

Entry Level

$48K/yr - $70K/yr

2+ years exp

Thermo Fisher Scientific is a company focused on enabling customers to make the world healthier, cleaner, and safer. The QA Engineer I will ensure product quality and regulatory compliance while supporting change management activities and driving continuous improvement initiatives within the quality management system.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

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

Qualification

Quality Management SystemsGMP ComplianceQuality AuditsContinuous ImprovementQuality DocumentationAnalytical SkillsProficient in Microsoft OfficeCommunication SkillsAttention to DetailProblem-Solving SkillsTeam Collaboration

Required

Must be legally authorized to work in the United States without sponsorship now or in the future

Must be able to pass a comprehensive background check, which includes a drug screening

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

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

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

Preferred

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

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

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