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IQC Technician, 2nd Shift

2 weeks ago

Fishers, Indiana, United States INCOG BioPharma Services Full time

Description

INCOG is looking for an Incoming Quality Control (IQC) Technician that has a passion for working within a team, a desire to drive Quality processes, and an eagerness to ensure Operations readiness from a Quality perspective. The IQC Technician will report to INCOG's IQC Supervisor and work closely with Supply Chain, Quality Control and Operations to support readiness of materials for manufacture of sterile, injectable products. The IQC Technician will perform routine sampling for components, API, BDS, and excipients undergoing QC testing, perform routine analytical techniques related to material testing and component inspection, and manage day-to-day tasks within the Incoming Quality Control laboratory including but not limited to: consumables ordering, daily instrument calibration/verification, laboratory waste management, laboratory/equipment cleaning, and sample shipment coordination to outside laboratories. The IQC Technician will be crucial in helping INCOG maintain efficient operational readiness by supporting our Quality Mindset with skills including attention to detail, on-time delivery, and commitment to Quality excellence.

Excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences is critical in this role. The IQC Technician will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, clients, suppliers, and partners. The IQC Technician will thrive in a team environment but can also work autonomously with strong self-management and organizational skills.

Essential Job Functions:

  • Be team oriented and act as a contributor to special projects when needed.
  • Sets deadlines and prioritizes work for self, group members, and support groups involved.  Reviews work performed by coworkers for accuracy and alignment with procedures.
  • Collaborates with internal departments and teams to resolve quality issues regarding materials needed for Operational campaigns.
  • Understands urgency and acts accordingly regarding turnaround times and release coordination.
  • Samples and inspects incoming materials.
  • Performs component visual inspection and dimensional analysis.
  • Performs instrument verifications as needed.
  • Generates/Reviews Certificates of Analyses (COA's) for materials release from IQC testing
  • Performs peer data review as needed.
  • Performs ordering of required outside testing and coordinates shipment of samples to outside laboratories.
  • Demonstrates excellent written and oral communication skills with the ability to clearly and concisely articulate complex issues to a range of target audiences.
  • Thrives in a team environment but can work autonomously with strong self-management and organizational skills.
  • Commits to a culture of quality with skills including attention to detail, on time delivery, and efficiency.
  • Upholds customer-centric mindset.

Special Job Requirements:

  • This position will support primarily second shift (3 pm to 11:30 pm).
  • Associate's Degree (Science discipline preferred) or High School Degree and minimum two (2) years' experience within the pharmaceutical/biopharmaceutical industry in Quality Control.
  • Strong math and documentation skills.
  • Strong oral and written communication and interpersonal interaction skills.
  • Ability to work in a highly regulated environment.
  • Ability to lift up to 50 lbs.
  • Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, QMS, etc.).

Additional Preferences:

  • Experience with statistical material sampling.
  • Experience within the pharmaceutical/biopharmaceutical industry-sterile manufacturing.
  • Experience reading and interpreting compendial test methods (USP/EP/JP specifically).
  • Experience in Quality Assurance/Quality Control.

Additional info about INCOG BioPharma Services:

At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.

If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.

INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind.  All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

By submitting your resume and details, you are declaring that the information is correct and accurate.