What are the responsibilities and job description for the Quality Control Chemistry Technician position at INCOG BioPharma Services?
Quality Control Chemistry Technician
INCOG Biopharma Services in Indianapolis, IN is hiring a Quality Control Technician (2nd shift). We are seeking a highly motivated individual who 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.
This role will also support lab organization/operation by performing activities such as supplies ordering, glassware washing and preparation, laboratory cleaning, and any other additional tasks deemed necessary for laboratory operation. Additionally, the role will include second person verification of analytical data, laboratory investigations support, and equipment calibrations and maintenance support may be required of this role. This is an entry/developmental position with opportunities to grow within the laboratory.
There is a growing need globally for more CDMOs (contract development and manufacturing organization) in the pharmaceutical industry to provide comprehensive services from drug development through drug manufacturing.
At INCOG, we are more than just a contract development and manufacturing organization. A better way to create more meaningful experiences. A better way to create a culture that everyone can thrive and succeed in. At our core, that is who we are—a dedicated team that believes we can always be better.
Join us at INCOG, a world-class CDMO for parenteral injectable drugs, shaping a new future for patients for yourself, our clients, and patients.
Job Functions:
- Perform sampling for Quality Control Chemistry Laboratory of 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.
- 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.
Candidate Requirements:
- Bachelor’s degree in science (Chemistry or Biochemistry preferred) or equivalent industry experience.
- Strong math, documentation, oral and written communication and interpersonal interaction skills.
- Ability to work in a highly regulated and fast paced environment.
- 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 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).
Why INCOG?
- Paid time off, based on tenure
- 11 observed holidays
- 401(k) plan with company match up to 3.5% of salary, vested immediately
- Choice of health & wellness plans
- FSA and HSA programs
- Dental & vision care
