Quality Control Compliance Specialist
Quality Control Compliance Specialist
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$ 74960 - 103070
1 Vacancy
Job Description
Our purpose is to bring hope to life by enabling lifechanging therapies for patients around the globe creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients lives by bringing new biopharmaceuticals to market.
JOB SUMMARY
TheQC Compliance Specialist is responsible for ensuring compliance of QC SOPs and quality records with regulatory guidelines. It requires attention to detail organization multitasking and the ability to interact with people of varying seniority levels. Responsibilities include internal and external audit support handling complex problems with indepth analysis and interacting crossfunctionally. This role coordinates compliance related workstreams with continuous improvement efforts to maintain efficient and compliant operations of the QC laboratory. The position requires minimal direction and involves analyzing procedures and managing change using creative solutions.
ESSENTIAL JOB DUTIES & RESPONSIBILITIES
Support QC regulatory inspection readiness
Supports owns authors and drives QC investigations CAPAs CRs IAIs and LIRs to closure.
Coordinates with quality systems and QC leadership to support ontime closure of quality records and represents QC in relevant governance teams
Create and update QC SOPs FRMs WOI and other GMP documents
Support proactive management of continuous improvement workstreams to drive operational efficiency and deviation reduction
Coach and collaborate with continuous improvement project owners
Other duties as assigned.
TECHNICAL & LEADERSHIP SKILLS
Strong understanding of cGMPs and quality systems
Knowledge and understanding of Lean Six Sigma and Human and Organization Performance (HOP) principles
Knowledge and understanding of Root Cause Analysis processes in a regulated environment
Demonstrated conflict resolution skills in a crossfunctional setting with the ability to keep objectives on track.
Demonstrated project management skills to accomplish deadlines and objectives.
Demonstrated ability to drive change management
Ability to multitask and work on various projects
EDUCATION & EXPERIENCE
Bachelors degree in Biology or a related science field with 57 years of relevant experience
Equivalent education and experience may substitute for stated requirements
QC laboratory and quality management system (MasterControl TrackWise etc. experience preferred
COMPENSATION
$74960 $103070
Our culture at AGC Biologics is defined by the six core values: Knowledge Trust Quality Ingenuity Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work sidebyside with our clients and partners every step of the way. We provide worldclass development and manufacture of mammalian and microbialbased therapeutic proteins plasmid DNA (pDNA) messenger RNA (mRNA) viral vectors and genetically engineered cells. Our global network spans the U.S. Europe and Asia with cGMPcompliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fasttrack projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit.Want to keep posted about our growth and learn more about our company Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age ancestry color family or medical care leave gender identity or expression genetic information marital status medical condition national origin physical or mental disability political affiliation protected veteran status race religion sexual orientation or any other characteristic protected by applicable laws regulations and ordinances.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
