Quality Assurance Associate I-III In Plant Operations

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

The Quality Assurance Associate I III (In Plant Operations) is responsible for providing 24/7/365 Quality support to the activities listed below at the Boulder CO site.

One Colorado one team. At our Boulder and Longmont locations we cultivate a unified team under the banner of One Colorado fostering collaboration among diverse teams and their respective business units. Together we leverage a shared services objective between the two sites to enhance care for our clients and their patients.

SCHEDULE: 223 Days

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Oversee Manufacturing floor operations and provide quality oversight.

• Specific Job Responsibilities include but not limited to:

• Review of executed manufacturing batch records for completeness compliance and accuracy to support product lot disposition.

• Review and approve logbook activities.

• Approve equipment and room changeover operations.

• Approve and execute area changeover operations.

• Support review and approval of Master Production Records (MPRs).

• Conduct review and approval of GMP documents (i.e. Standard Operating Procedures (SOPs) Forms Work Instructions etc. in the electronic Document Management System.

• Support Deviations CAPAs and Change Control when required.

• Collaborate in the resolution of issues associated with the manufacturing operations with the QA pointofcontact to provide guidance and facilitate the resumption of manufacturing activities post deviation detection.

KNOWLEDGE SKILLS AND ABILITIES

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.

• Technical and analytical understanding of Biologics Manufacturing and testing.

• Knowledge of regulatory compliance principles strategy and rational as they relate to Biologics Manufacturing.

• Good oral and written communication skills.

• Good organizational skills.

• Demonstrated experience in areas of teamwork and problemsolving.

• Ability to work on moderately complex problems where analysis of situations or data requires an evaluation of factors.

• Understanding of basic scientific/technical concepts

EDUCATION and/or EXPERIENCE

• Bachelors degree in Biology Chemistry or other relevant science/engineering discipline or equivalent work experience.

• Previous experience in QA or related document control experience as required below:

• Associate I 0 2 years

• Associate II Minimum 2 years

• Associate III Minimum 5 years

• Equivalent education and experience may substitute for stated requirements

COMPENSATION:

$48484 $103070

Level I and II will be paid hourly.

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.