The Chemist in the DC In-Process Laboratory performs accurate and timely testing of routine and some non-routine lab samples in accordance with appropriate GMP and safety guidelines. This individual completes second person verification of others results and also assists in laboratory root cause investigations, equipment evaluations and qualifications, and some quality system improvement initiatives by performing well-defined protocols and procedures. The Chemist shares technical information and best practice within plant sites or group.

Responsibilities:

• Verify (SPV) analytical data of other analysts within the lab as requested.
• Accurately and safely perform analytical test methods or related support activities as per procedures or protocols. Uses technical knowledge in the review and interpretation of data for conformance to procedures, standards and protocols and/or real-time recognition of aberrant data and results.
• Perform data entry and review work ensuring accuracy in accordance with laboratory procedures, standards and GMP requirements.
• May perform comprehensive review of data for release of data from the laboratory.
• Recognizes when a deviation from procedures, etc has occurred and initiates and participates in a Root Cause Investigation.
• Performs investigations for deviations.
• Troubleshoot equipment and methods as required.
• Assist in improvement of quality systems by crafting or revising worksheets and other lab documentation systems.
• Evaluates and communicates opportunities for improvement initiatives in daily work activities.
• Contribute to development of PQEs.
• Reviews SOPs for executable as written.
• Shares technical information and best practice within plant sites or group.
• Write protocols for non-routine testing or validation with appropriate guidance.
• Develops equipment qualification protocols with appropriate guidance.
• Perform routine equipment calibrations or maintenance through execution of well- defined protocols.
• Follow and implement safety standards.
• Handles notification to management when required by procedures or standards.
• Initiate change controls and deviations.
• Train and mentoring others. Develop training materials.

Basic Qualifications:

• Bachelor degree required, preferably in Chemistry.
• 1+ year experience in a GMP analytical chemistry lab required.

Additional Skills:

• Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
• Proficiency with computer systems including Microsoft Office products, LIMS (list other lab systems), etc.
• Ability to working in a lab environment including wearing appropriate PPE and other safety required equipment and considerations.
• Demonstrated strong math and documentation skills.
• Demonstrated strong oral and written communication and interpersonal interaction skills.

Other Information:

• Work schedule: 10 Hour Nights (Monday-Thursday or Tuesday-Friday)
• Rotating On-Call Weekend Coverage
• May be required to have a company phone off shift and respond to operational issues.
• Minimal travel required.
• Applicant will work in various areas within the Parenteral Plant. Some allergens are present in the parenteral plant. Mobility requirements and exposure to allergens should be considered when applying for this position
• Tasks may require repetitive motion (e.g., keyboarding).
• Post-offer testing exam may be required.