Quality Assurance Officer

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.

DESCRIPTION:
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 that make the world healthier cleaner and safer. 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.

REQUIREMENTS:

Education & Background

• Bachelors Degree required in a scientific or technical discipline

• Preferred fields: Chemistry Biology Biotechnology Engineering or related discipline

• Additional certifications or training in Quality Systems GMP or ISO standards are preferred

Experience

• 2 to 3 years of experience in a GMP-regulated or quality-controlled environment

• While the role is open to early-career candidates 3 years of hands-on GMP and/or Quality experience is strongly preferred particularly in pharmaceutical or highly regulated manufacturing environments

• Prior experience in pharmaceutical biotech medical device or other regulated industries is strongly preferred

• Experience working within controlled manufacturing or laboratory environments is highly desirable

GMP Quality & Regulatory Knowledge

• Foundational to working knowledge of cGMP requirements; prior exposure in a regulated setting is highly advantageous

• Working knowledge of ISO standards (ISO 13485 ISO 9001) and applicable international regulatory requirements

• Experience with quality systems and controlled documentation including:

  • Batch records (real-time and/or post-production review)

  • SOPs and work instructions

  • Deviations non-conformances and CAPAs

• Experience supporting internal audits and external regulatory inspections preferred

Systems & Tools

• Experience with QMS tools such as TrackWise SAP EDMS / electronic document management systems

• Prior experience is advantageous but not critical; training can be provided

Core Skills & Competencies

• Strong attention to detail with demonstrated accuracy in documentation review

• Analytical and problem-solving skills including deviation investigations root cause analysis and CAPA development

• Excellent written and verbal communication skills

• Ability to work independently while collaborating with Operations QC Engineering and Quality Systems

• Ability to prioritize tasks in a fast-paced regulated environment

• Proficiency in Microsoft Office (Word Excel PowerPoint)

Continuous Improvement

• Exposure to Lean or Six Sigma methodologies is preferred but not required

Work Environment & Logistics

• Up to 10% travel may be required (e.g. support of other sites such as Banyo)

• Ability to work in controlled environments including use of required PPE and adherence to cleanroom and GMP protocols