Lead a QC raw materials testing program to support commercial manufacturing.
Oversee the inspection, sampling, and testing of incoming raw materials prior to use in manufacturing, according to US and EU GMP requirements.
Ensure materials are sampled in accordance with SOPs, entered into the data management systems, and are available for use on time.
Participate in the qualification of raw materials via external and in-house testing.
Serve as subject matter expert in review of raw material specifications.
Participate in vendor audits as a technical advisor.
Oversee the daily routine activities of the raw materials group, provide data review, and ensure the operation remains compliant at all times.
Collaborate with Quality Assurance, Manufacturing, Materials Management, external vendors, and other functions to ensure internal timelines, testing TAT, and team milestones are achieved.
Author and maintain required cGMP documentation such as SOPs and guidance documents.
Oversee verification of assays at external testing labs.
Identify gaps, design collaborative solutions, and implement improvements.
Participate in external testing labs QC laboratory investigations, deviations, OOS, and CAPAs.
Support onboarding and qualification of analytical equipment.
Requirements
BS in Chemistry, or related field with a minimum of 5+ years of relevant experience within the pharmaceutical industry and a minimum of 3+ years of hands-on, industry experience managing in a cGMP QC laboratory.
Extensive experience with raw material sampling, including handling of powders and liquids, using aseptic techniques.
Knowledge of cGMP raw materials tests including pH, conductivity, osmolality, moisture, appearance, FTIR, HPLC, etc.
Knowledge of verification and validation of assays required for raw material testing.
Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA).
Extensive knowledge of GDPs, GMPs multi-compendial assays (USP, EP, JP).
Excellent communication and collaboration skills.
Attention to detail, highly organized, able to meet schedules and timelines and handle multiple priorities.
Why Join Us:
Growth Opportunities : We're a company that believes in continuous learning and development. Whether it's professional courses, mentorship, or new projects, we'll help you grow.
Flexible Work Environment : We offer flexible work options to help you balance your professional and personal life. This is a site role.
Inclusive Culture : We're committed to building a diverse and inclusive environment where everyone's voice is valued, and curiosity is encouraged.
Innovative Projects : You'll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
A Place for Big Ideas : We don't just talk about thinking outside the box-we throw the box away. If you've got ideas, we want to hear them.
Are You Still Curious?
If you've read this far, then chances are you've got a curious mind-just like us. So, what are you waiting for? Take the leap and apply today. We can't wait to see where your curiosity leads you-and how it will shape the future of Just Evotec Biologics .
Let your curiosity guide your career- #BeCurious and explore the endless possibilities
Benefits
Flexible schedule
Additional Information
Job Title: QC Manager, Raw Materials
About Us: this is who we are
At Just Evotec Biologics , we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what's possible. We're on a mission to create a place where curiosity isn't just encouraged-it's celebrated.
Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCureious with us and see where your curiosity can take you!
The Role: / your challenge, ...in our journey
We're looking for a passionate and curious QC Manager, Raw Materials to join our team. If you're excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you'll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories.
As a QC Manager, Raw Materials at Just Evotec Biologics , you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It's a role where your curiosity will fuel both your personal growth and the success of the team.
Position
This position oversees and participates in the sampling and testing of incoming raw materials prior to their use in cGMP manufacturing. This role works collaboratively with other teams to ensure that raw materials are released in a compliant manner prior to their need-by dates. The role requires extensive cGMP compliance experience, exceptional attention to detail, and experience designing and implementing efficiency improvements.
Evotecgroup · Redmond