Just Evotec Biologics
pharmaceutical
QCManager,RawMaterials
Neural analysis suggests this role is
optimal for Manager candidates.
“QC Manager, Raw Materials at Just Evotec Biologics. Skills: QC raw materials testing program leadership, cGMP compliance, raw material sampling and testing, regulatory requirements knowledge. Oversee and participate in the sampling and testing of incoming raw materials prior to their use in cGMP manufacturing. Lead a QC raw materials testing program to support commercial manufacturing”
What You'll Achieve.
ensure that raw materials are released in a compliant manner prior to their need-by dates; ensure internal timelines, testing TAT, and team milestones are achieved; ensure the operation remains compliant at all times
Industry & Context.
solving complex problems; find creative solutions; Identify gaps, design collaborative solutions
What They're Looking For.
Must Have
BS in Chemistry, or related field, minimum of 5+ years of relevant experience within the pharmaceutical industry, 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)
What You'll Do.
Oversee and participate in the sampling and testing of incoming raw materials prior to their use in cGMP manufacturing
Lead a QC raw materials testing program to support commercial manufacturing
Oversee the inspection
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
and ensure the operation remains compliant at all times
Author and maintain required cGMP documentation such as SOPs and guidance documents
Oversee verification of assays at external testing labs
design collaborative solutions
and implement improvements
Participate in external testing labs QC laboratory investigations
Support onboarding and qualification of analytical equipment
How You'll Work.
Team & Collaboration
Collaborate with Quality Assurance, Manufacturing, Materials Management, external vendors, and other functions to ensure internal timelines, testing TAT, and team milestones are achieved; Participate in vendor audits as a technical advisor; design collaborative solutions
Communication Scope
Excellent communication and collaboration skills
Process & Methodology
drive impactful projects, manage multiple priorities, meet schedules and timelines
Full Job Description
**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. **What You’ll Do:** * 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 accord
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