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Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, No eye contacts allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials
Job Description
At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.
Position summary:
Reporting to the QC Manager Chemistry, the role is responsible for building a new, pioneering, GMP QC lab. This role is responsible for writing laboratory procedures, transfer/verification/validation of methodology, and project work within the department to support manufacture and release of pharmaceutical raw materials, intermediates and products. The role gives to building and maintaining QC lab cGMP system, delivers analytical solution to clients through expertise in specific method qualification and validation strategies while ensuring timely delivery for projects. The role will be driving activities such as testing for incoming materials, in-process products and DS testing, etc.
Responsibilities:
To support new equipment qualification, lab computerized system and new chemistry lab set up
To perform transfer/verification/validation of laboratory procedures within the team where required
To prepare technical documentation including but not limited to protocols, analytical write-ups, standard operating procedures, specifications, investigations and reports.
To perform analysis of incoming goods, intermediates and/or finished products under cGMP conditions for QC release or as part of stability studies.
To review analytical and laboratory data within the department for accuracy, completeness and compliance with detailed procedures.
To perform planned preventative maintenance and performance calibrations on equipment.
Management of QC chemical, reference standard and consumable stock levels
To maintain own training records and support and train other team members as required.
Participate/chip in Practical Process Improvement initiatives (PPI) or continuous improvement in the lab
Support and encourage a “Quality Culture” and company 4i values throughout QC
Ensure cGMP is applied in their area of work and align with cGMP in all areas of the business.
To work with HSE, cGMP and 5S in mind at all times.
Undertake ad-hoc activities that may be required by the business
To support shift work (if necessary) in future
Keys to Success:
Education
Experience
At least 3 years relevant industrial experience
Ability to apply GMP regulations and other international guidelines to all aspects of the position.
Ability to work independently and adhere to critical timelines
Excellent attention to detail
Excellent organisational skills
Benefits
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 100,000+ 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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.