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Description
Job Summary
The Quality Control Technician will be a member of the Quality Control Department. As a member of the team, he/she/they will be involved in routine QC sampling and testing of utilities, raw materials, in-process/finished product/stability drug product and incoming components in accordance with GMP (Good Manufacturing Practices) and safety guidelines. Technician will also support lab organization/operation by performing activities such as supply ordering, glassware washing and preparation, laboratory cleaning, and any other additional tasks deemed necessary for laboratory operation. Additionally, tasks including but not limited to second person verification of analytical data, laboratory investigations support, and equipment calibrations and maintenance support may be required of this role. The Quality Control Technician is an entry/developmental position with opportunities to grow within the laboratory.
This is a 3rd Shift Position. Hours: 11pm-7:30am
Essential Job Functions:
• Be team oriented and willing to act as both a facilitator of special projects and a contributor to special projects when needed.
• Ability to set deadlines and prioritize work for self, group members, and support groups involved. Ability to review/approve work performed by coworkers for accuracy and alignment with procedures.
• Collaborate with internal departments and teams to resolve quality issues regarding facility, products manufactured and released, and goods ordered for the laboratory.
• Handle and dispose of Laboratory waste while adhering to Environmental, Health, & Safety standards required in a GMP lab.
• Performs sample management activities for Quality Control Chemistry Laboratory including management of samples from clean utilities, components, raw materials, in-process samples, finished product samples, and stability samples
• Perform common chemistry testing on utilities samples, incoming components and raw materials, in-process samples, finished product samples, and stability samples according to validated methods as well as special testing deemed necessary by special testing or protocols.
• Perform common laboratory procedures such as pH, weighing with analytical balances, glassware washing/preparation, daily equipment calibration verifications, and peer review of test parameters and reagent preparations.
• Assist, as needed, with sample preparation and testing related to but not limited to validation protocols, laboratory studies, and cleaning validations.
• Execute work orders and routine preventative maintenance on QC laboratory instrumentation, as needed, using written SOPs, work order directive or be available assist/escort vendors with access to systems/materials when vendors perform maintenance.
• Provide support during laboratory investigations when needed.
• Maintain laboratory documentation to ensure organization and regulatory compliance.
Special Job Requirements:
• 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.
• Bachelor's degree in science (Chemistry or Biochemistry preferred) or equivalent industry experience.
• Strong math and documentation skills
• Strong oral and written communication and interpersonal interaction skills.
• Ability to work in a highly regulated and fast paced 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, JMP, Minitab, etc.)
Additional Preferences:
• Working knowledge of laboratory instrumentation such as pH meters, UV/VIS, FTIR, UHPLC/HPLC/GC, TOC analyzer, density meter and freezing point depression osmometer.
• Experience with Good Documentation Practices (GDP) and other GxP principles.
• Experience with Continuous improvement, Six Sigma, and/or Lean principles.
• Experience in an isolator-based aseptic drug product manufacturing facility.
• Experience performing container closure integrity testing (CCIT).
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.