IQC Scientist

INCOG BioPharma Services•Fishers, IN

4d•Onsite

About The Position

INCOG BioPharma Services is seeking an Incoming Quality Control (IQC) Scientist – Physical Testing to join our Quality Control team in Fishers, Indiana. This role is critical in executing and maintaining the physical testing program for incoming components, in-process samples, and finished drug products, with a primary focus on sterile injectable drug products including autoinjectors and pre-filled syringes. The IQC Scientist – Physical Testing is responsible for generating ALCOA+ data, upholding INCOG's Quality Mindset, and ensuring all physical testing activities are performed in compliance with applicable SOPs, client specifications, and regulatory requirements. The IQC Scientist will work closely with the IQC Manager, Quality Assurance, Manufacturing, and Technical Services teams to support routine physical testing, material qualification activities, and new product introduction (NPI) initiatives. This role requires hands-on proficiency with specialized physical testing instrumentation and a working knowledge of applicable ISO standards, FDA/EMA regulatory expectations, and statistical sampling principles. The IQC Scientist – Physical Testing will thrive in a collaborative team environment while demonstrating strong self-management and organizational skills to execute independently when needed.

Requirements

Bachelor's Degree in a scientific discipline (Chemistry, Biology, Pharmaceutical Sciences, Engineering, or related field).
Minimum of 3+ years of biopharma or pharmaceutical industry experience, with at least 2 years of hands-on experience in a GMP-regulated Quality Control environment.
Demonstrated hands-on experience executing physical testing of sterile injectable drug products, including autoinjectors and/or pre-filled syringes, in a GMP setting.
Proficiency in operating physical testing instrumentation, including Zwick universal testing machines, High Voltage Leak Detection (HVLD) instruments, and force gauge systems.
Experience with container closure integrity testing (CCIT) methodologies, including HVLD.
Working knowledge of FDA, EMA, and other regulatory authority expectations applicable to QC physical testing in a GMP environment.
Working knowledge of applicable ISO standards for injection systems and quality management systems, including ISO 11608 series, ISO 23908, and ISO 13485.
Experience with statistical sampling principles, AQL establishment, and defect criteria development based on ANSI/ASQ Z1.4 requirements.
Must pass an initial and annual health and visual check, including eye inspections for visual acuity and color blindness. Failure to meet visual requirements or pass annual recertification may affect continued eligibility for this role.
Experience with laboratory investigations, OOS/OOT event handling, and deviation documentation in a GMP quality system.
Exceptional computer skills evidenced by hands-on experience with automated data management and/or data analysis systems (LIMS, JMP, Minitab, or equivalent)

Nice To Haves

Experience with assembled autoinjector functional testing per ISO 11608-5.
Familiarity with USP <1207> Container Closure Integrity Testing guidance.
Experience with AQL establishment per ANSI/ASQ Z1.4 and defect criteria development aligned with PDA Technical Report guidance.
Experience participating in and/or hosting FDA, EMA, or client GMP audits/inspections.
Experience with ERP systems such as SAP in a GMP manufacturing or CDMO environment.
Advanced degree (M.S., M.Eng., or equivalent) in a relevant scientific or engineering discipline.

Responsibilities

Execute routine and batch-related physical testing on incoming components, in-process samples, and finished drug products in compliance with applicable SOPs, client specifications, and regulatory requirements.
Perform container closure integrity testing (CCIT) using High Voltage Leak Detection (HVLD) instrumentation in accordance with applicable methods and acceptance criteria.
Conduct force and functional testing of drug delivery devices, including glide force and break-loose force testing using Zwick universal testing machines, needle cap and needle shield removal force testing, cap removal force testing, and activation force and trigger force testing for autoinjectors.
Support the INCOG material qualification program by executing physical sampling and testing of incoming components and raw materials according to established sampling plans and material specifications.
Assist in the development, revision, and execution of protocols for physical test method transfers, method validations, and equipment qualifications.
Author and revise SOPs, work instructions, and certificate of analysis (COA) templates related to physical testing activities.
Participate in laboratory investigations and deviations as a subject matter expert (SME), applying troubleshooting tools to identify root causes of OOS/OOT results and support implementation of corrective actions.
Perform visual inspection of incoming components and drug product in accordance with applicable specifications and acceptance criteria, including AQL-based sampling per ANSI/ASQ Z1.4.
Ensure all physical testing instrumentation is properly maintained, calibrated, and documented; execute routine laboratory work orders for equipment maintenance and non-critical calibrations.
Record and review physical testing data in compliance with ALCOA+ principles using LIMS and other applicable quality and data management systems.
Review and approve physical testing data generated by peers for accuracy and alignment with procedures.
Participate in new product introduction and technology transfer projects by supporting physical testing readiness activities and equipment qualification efforts ahead of manufacturing milestones.
Support client audits and regulatory inspections as a subject matter expert for physical testing operations.