Quality Assurance Associate I-III (In Plant Operations)

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

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: 2-2-3 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 change-over operations.

• Approve and execute area change-over 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 point-of-contact, 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 problem-solving.

• 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

• Bachelor’s 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:

$48,484 - $103,070

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 delive