Quality Assurance Associate III
Apply NowCompany: AGC Biologics
Location: Washington, DC 20011
Description:
Our purpose is to bring hope to life by enabling life-changing 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
Responsible for administration of Quality Operations Activities associated with material management and release, lot disposition, and in-plant QA in compliance with applicable regulatory guidelines and requirements.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES
LEADERSHIP SKILLS
QUALIFICATIONS
Required:
SCHEDULE - MONDAY TO FRIDAY 08 am to 5 pm
COMPENSATION $74.960 to $ 103.070
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 side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based 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 cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. 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.
JOB SUMMARY
Responsible for administration of Quality Operations Activities associated with material management and release, lot disposition, and in-plant QA in compliance with applicable regulatory guidelines and requirements.
ESSENTIAL JOB DUTIES/RESPONSIBILITIES
- Review and approve controlled documents including analytical assays, Standard Operating Procedures, Manufacturing Batch Records, and Validation protocols and reports.
- Review material release documentation and disposition materials for use in cGMP manufacture.
- Review QC data generated from manufactured product and intermediates and stability testing and approve results summaries.
- Review and approve simple Change Requests, simple deviations and corresponding CAPA.
- Support in-plant operations by conducting in-plant review of batch records and providing QA support for operations.
- Review executed manufacturing batch records for completeness, compliance, and accuracy and partner with others for corrections as necessary.
- Create and review documents to be included in DHRs.
- Review and approve equipment onboarding and preventative maintenance and repair work orders.
- Participate and lead Improvement initiatives aimed to add efficiency to the Quality processes.
- Supports or may lead multiple more complex projects/initiatives/work items under broad supervision.
- Analyzes issues and makes decisions based on standardized processes and procedures under close supervision.
- Communicates moderately complex concepts and interacts with others to inform and direct action.
- Acts as a resource for less experienced team members and colleagues.
LEADERSHIP SKILLS
- Analyzes multiple sources of information and evaluates several alternative solutions before confirming correct path.
- Explains complicated information and effectively lays out variations of alternatives to consider.
- Works across teams effectively.
- Applies understanding of how the team relates to other closely related areas to improve efficiency of own team.
QUALIFICATIONS
Required:
- BS/BA degree and 5+ years of relevant experience. Equivalent education and experience may substitute for stated requirements.
SCHEDULE - MONDAY TO FRIDAY 08 am to 5 pm
COMPENSATION $74.960 to $ 103.070
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 side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based 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 cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients' most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com. 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.