The Senior Chemist is responsible for laboratory scheduling prioritization and workload distribution in the drug product lab, including stability, vaccine, drug product and raw material testing. They will also perform LIR supervisor duties for atypical, OOS, questionable and invalidated data occurrences and will cover data integrity responsibilities. The chemist will also be responsible for process improvement for DP release and stability testing.
The Chemist represents and/or leads the lab unit or the entire lab organization on high complexity projects and project teams both within and outside of Quality Operations, to include but not be limited to data integrity initiatives, PQS compliance requirements and continuous improvement projects.
This role provides leadership and technical expertise to assist the laboratory with troubleshooting, investigations, computer validation and instrument qualifications. The Chemist may be involved in second checking of data and will perform assays as needed.
The Chemist will be directly involved in implementation of system conversions (i.e. Empower 3, gLIMS), they may also assist with method improvements as well as other infrastructure support functions.
This role has the responsibility of serving as Management Designee and will have limited input into the OTE colleague performance assessment process. The Chemist may defend QC Laboratory Quality Systems during audits and inspections.
• Leads and documents laboratory investigations for procedural deviations, atypical, OOS, questionable, and invalidated data occurrences.
• Assures adherence to data integrity initiatives.
• As a Subject Matter Expert (SME), represents the lab unit or the entire lab organization on high complexity projects and project teams both within and outside of QO. Leads medium or high complexity project teams within QO tasked with improving laboratory or other quality systems.
• Assists QO Lab leadership in determining scheduling priorities and workload distribution to ensure customer needs are met.
• Performs data quality inspection through Quality audits and 2nd check of laboratory data packets
• Performs analytical assays during times of need.
• Demonstrates a technical mastery of one or more techniques in fields such as: wet chemistry, chromatography, physical chemistry, or spectroscopy as well as a complete knowledge of laboratory operations including both technical and compliance aspects.
• Applies knowledge of advanced techniques and procedures with recommendations and implementation of new or modified procedures or instrumentation for improved lab efficiency.
• Trains others in the theory and practice of both laboratory techniques and quality systems including investigations, instrument qualifications, etc.
• Independently writes SOPs, technical reports, project plans, instrument qualifications, etc.
• Serves as management designee and will have limited input into the OTE colleague performance assessment process.
BA/BS, or MS in Chemistry, Biochemistry, or related science preferred with a minimum of 5 years related experience in Quality Operations.
+ LIR / RAAC / MIR Author
+ Trained to execute and record check multiple Chemistry laboratory technologies
+ Prior experience with Equipment Qualifications
Job requires sitting, standing, walking, ability to type, and dexterity for handling glassware/laboratory equipment.
+ **Other Job Details:**
+ **Last Date to Apply for Job: April 12, 2021**
+ Eligible for Employee Referral Bonus: Yes
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**EEO & Employment Eligibility**
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Quality Assurance and Control