QC Supervisor/Manager, Raw Materials
Company: Evorec Group
Location: Redmond
Posted on: July 30, 2022
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Job Description:
Just is seeking a highly motivated individual who desires a
significant opportunity to improve worldwide access to
biotherapeutics. The candidate will provide leadership in a fast
paced, collaborative QC group. The candidate will oversee and
participate in the sampling and external testing of incoming raw
materials prior to their use in cGMP manufacturing. The candidate
will work collaboratively with other teams to ensure that raw
materials are released prior to their need by dates in compliant
manner. The successful candidate will have extensive cGMP
compliance experience, exceptional attention to detail and have
experience designing and implementing efficiency improvements.
Responsibilities:Lead a QC raw materials testing program to support
commercial manufacturingOversee the inspection, sampling, and
external testing of incoming raw materials prior to use in
manufacturing, according to US and EU GMP requirementsEnsure
materials are sampled in accordance to SOPs, entered into the data
management systems, and are available for use on timeParticipate in
the qualification of raw materials via external testingLead the
implementation of a Raman based ID testing programServe as subject
matter expert in review of raw material specificationsParticipate
in vendor audits as a technical advisorOversee the daily routine
activities of the raw materials group, provide data review and
ensure the operation remains compliant at all timesCollaborate with
Quality Assurance, Manufacturing, Material Management, external
vendors, and other functions to ensure internal timelines, testing
TAT, and team milestones are achieved. Provide expertise for the
IOPQ of Raman instrumentation for raw material ID testing,
including troubleshooting and routine equipment maintenanceAuthor
and maintain required cGMP documentation such as SOPs and guidance
documentsOversee verification of assays at external testing
labsIdentify gaps, design collaborative solutions, and implement
improvementsParticipate in external testing labs QC laboratory
investigations, deviations, OOS, and CAPAsRequirements:BS in
Biochemistry, Chemistry, or related field with > 5-8 years cGMP
experience with raw materialsExtensive experience with raw material
sampling, including handling of powder and liquids, using aseptic
techniquesKnowledge of cGMP raw materials tests including pH,
conductivity, osmolality, moisture, appearance, HPLC, etc.Knowledge
of verification and validation of assays required for raw material
testingExperience with Raman for IDExtensive knowledge of
regulatory requirements and guidelines (ICH, CFR, FDA) Extensive
knowledge of GDPs, GMPs multi-compendial assays (USP, EP, JP)
Excellent communication and collaboration skillsAttention to
detail, highly organized, able to meet schedules and timelines and
handle multiple prioritiesMiddle Management
Keywords: Evorec Group, Redmond , QC Supervisor/Manager, Raw Materials, Executive , Redmond, Washington
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