Associate QC Chemist, 3rd Shift

Lead Candidate; Indiana (PA); On-site; USD 75,000 - 115,000; Full time

Benefits offered by this job

Paid time off

11 paid holidays

401(k) with company match

Health & wellness plans

FSA/HSA options

Onsite wellness facility

Employee engagement activities

Job summary

INCOG is seeking a Quality Control (QC) Chemist to join the Quality Control Chemistry laboratory on the third shift (11 pm to 7:30 am). You will perform routine and batch-related testing on incoming components, raw materials, in-process samples, finished product, and stability samples using validated methods.

The role requires a Bachelor's in Chemistry or Biochemistry, 3+ years in biopharma GMP, strong data integrity practices, and experience with UHPLC/HPLC, GC, UV-VIS, TOC, and

Qualifications

• Bachelor's Degree in Science (Chemistry or Biochemistry).
• 3+ years in biopharma GMP/Quality Control in a regulated environment.
• Proficiency with UHPLC/HPLC, GC, UV-VIS, TOC and related instruments.
• Experience with FDA/EMA regulatory expectations for QC.
• Hands-on with data management systems (LIMS, JMP, Minitab).

Responsibilities

• Perform routine and batch-related testing on components, materials, in-process and finished products.
• Assist in sampling and testing of incoming materials.
• Create/revise SOPs and related QC documents.
• Support investigations/deviations and provide SME input.
• Troubleshoot methods, equipment, and analyses; perform maintenance on QC instrumentation.

Skills

UHPLC/HPLC

GC

TOC

UV-VIS

Data integrity

LIMS

JMP

Minitab

Education

Bachelor's Degree in Chemistry or Biochemistry

Tools

SOPs

Job description

INCOG is seeking a Quality Control (QC) Chemist with a passion for working within a team, a desire to drive Quality processes in a regulated setting, and a commitment to upholding the integrity of data generated for clients.

The QC Chemist will work closely with the QC Chemistry Manager and Quality Control Method Transfer Scientists, as well as Project Management and Supply Chain teams, to support development, readiness, and routine testing activities for the Quality Control Chemistry laboratory.

This role is crucial in generating ALCOA+ data and upholding our Quality Mindset through attention to detail, on-time delivery, and commitment to Quality excellence. Strict adherence to Good Documentation Practices (GDP) is required as Good Manufacturing Practice (GMP) testing is performed.

WHAT?

• This position will support primarily third shift (11 pm to 7:30 am)
• Perform routine and batch-related testing on incoming components, raw materials, in-process samples, finished product, and stability samples according to validated methods as well as special testing deemed necessary by protocols
• Assist in sampling and testing of incoming materials requiring QC testing as needed
• Create/revise SOPs and other relevant documents related to laboratory equipment and/or processes
• Participate in the completion of laboratory investigations/deviations and provide SME support where needed
• Perform basic troubleshooting activities with respect to methods/assays, equipment malfunctions, and investigations (Deviations and OOS)
• Execute routine laboratory work orders for maintenance and non-critical calibrations
• Perform minor preventative maintenance on QC laboratory instrumentation as needed using written SOPs or assist vendors with access to systems/materials when vendor performs maintenance

YOU!

• Bachelor's Degree in Science (Chemistry or Biochemistry)
• Minimum of 3+ years of biopharma industry experience, with at least 2 years of hands-on experience in a GMP environment/Quality Control testing in a regulated environment or other related experience
• High proficiency level in operating UHPLC/HPLC, GC, SoloVPE, UV-VIS, TOC, particulate matter analyses, method validation/transfer, and relevant laboratory computer systems with associated data integrity requirements
• Excellent working knowledge, understanding, and experience with practical implementation of FDA, EMA, and other regulatory authority expectations for Quality Control
• Exceptional computer skills evidenced by hands-on work with automated data management and/or data analysis systems (LIMS, JMP, Minitab, etc.)

Why INCOG?

• Paid time off, based on tenure
• 11 paid holidays
• 401(k) plan with company match up, vested immediately
• Choice of health & wellness plans
• FSA and HSA options
• Onsite wellness facility
• Employee engagement activities; food trucks, monthly luncheons, fundraising events, team building competitions, offsite celebrations

Don’t meet all the requirements? Don’t sweat! We’re always looking for an excuse to discuss your next opportunity. You might just surprise yourself…

Lead Candidate wholeheartedly supports Equality and Diversity in employment and opposes all forms of unlawful or unfair discrimination on the grounds of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.