QC Chemist, 3rd Shift

INCOG BioPharma Services•Fishers, IN

15d•Onsite

About The Position

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. 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 QC Chemist will exemplify excellent interpersonal skills and be capable of developing productive, customer-centric working relationships with colleagues, clients, suppliers, and partners. The QC Chemist will thrive in a team environment but can also work autonomously with strong self-management and organizational skills.

Requirements

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.)

Nice To Haves

Experience with Continuous Improvement, Six Sigma, and/or Lean principles
Experience with building processes and procedures
Experience in performing testing and/or characterization of biologic (monoclonal antibody, enzyme) and small molecule (peptide, mRNA) products
Experience performing container closure integrity testing (CCIT)

Responsibilities

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
Execute day-to-day tasks within the laboratory including sample inventory disposition/disposal, consumables ordering/inventory, preparing instruments for testing, and laboratory waste management
Assist in the control and management of laboratory waste in cooperation with relevant EH&S standards
Assist in the development and execution of protocols for method transfers, method validations, stability studies, cleaning validations, and any other special testing required from the Quality Control Chemistry laboratory
Support internal and external customers to ensure proper and timely execution of all aspects of the clinical/commercial analytical method life cycle across clients
Conduct periodic reviews of analytical test procedures and SOPs as required
Review and approve analytical testing procedures and protocols as needed
Assist in training fellow QC and Development personnel on instruments and assays when cross-training is needed
Assist in the professional support and development of QC Chemistry Technician staff within the QC laboratory
Be team-oriented and willing to act as both a facilitator of special projects and a contributor to special projects when needed
Set deadlines and prioritize work for self, group members, and support groups involved
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
Identify, evaluate, and implement continuous business process improvements