QC Scientist I
Thermo Fisher Scientific

Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, 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

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. 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 world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Excellent Benefits Package

Review our company's Total Rewards

Medical, Dental, & Vision benefits-effective Day 1

Paid Time Off & Holidays

401K Company Match up to 6%

Tuition Reimbursement - eligible after 90 days!

Employee Referral Bonus

Employee Discount Program

Recognition Program

Charitable Gift Matching

Company Paid Parental Leave

Career Advancement Opportunities

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

• Bachelor's Degree in Chemistry or strongly related scientific field

• No experience required
• 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