SUMMARY:
We are seeking an experienced and highly skilled Chemist III to support our Quality Control (QC) operations within a pharmaceutical manufacturing environment. This role requires expertise in analytical testing of Finished Products, Raw Materials, and stability samples, as well as experience in method development, validation, and transfer. The ideal candidate will possess advanced technical knowledge in HPLC, GC, and Chromatography Data Systems (preferably Empower 3), with strong troubleshooting and data analysis skills. As a Subject Matter Expert (SME), the candidate will oversee laboratory instrumentation, ensure compliance with cGMP and regulatory standards (USP, EP, JP, ICH, FDA), and contribute to continuous improvement in laboratory processes. This is a hands-on role involving regular interaction with internal teams, contract laboratories, and cross-functional partners to ensure timely and accurate testing and documentation in a dynamic, fast-paced environment.
Work Schedule: Monday - Friday 8am-4:30pm
JOB QUALIFICATIONS:
BS/MS in Chemistry or related Scientific Discipline with a minimum of 4 years of pharmaceutical experience or equivalent combination of education and experience with testing Finished Products, Raw Materials, and Analytical Method Verification, Validations and Transfers.
Advanced technical skills in HPLC and GC required, including theoretical understanding of technique, troubleshooting, maintenance and consumable replacements.
Advanced level of Chromatography Data Software (CDS) preferably Empower 3.
Ability to enable quantification for assays and impurities calculations, create custom calculations, and design chromatographic reports in CDS.
Able to interpret data, including evaluation of stability testing for trends.
Demonstrated use of analytical techniques in support of product development activities.
Comprehensive knowledge of current Good Manufacturing Practices (cGMP), regulatory requirements, and ICH Guidelines.
Understanding and adherence with CFR 21 Part 11 requirements.
Understanding, Knowledge, and performing of Raw Material qualifications of new incoming raw materials along with annual review requirements for existing Raw Materials.
Comprehension and ability to follow procedures of various pharmacopeias (USP, EP, JP).
Comprehension of regulated guidance (WHO, FCC, FDA, and ICH).
Understanding and basic regulatory requirements and applies knowledge appropriately to activities.
Demonstrated ability to work well in a fast-paced setting with teams.
Self-starter with a strong work ethic.
Must possess problem solving skills.
Must be able to operate with minimal supervision.
Demonstrated ability to train and/or mentor employees.
Excellent written and verbal communication skills.
POSITION RESPONSIBILITIES:
Serve as the SME for analytical methods, instrumentation, and QC processes.
Ensure proper calibration, maintenance, and troubleshooting of lab equipment.
Assist and or coordinate in routine and non-routine QC testing of raw materials, in-process samples, Stability and Finished Products.
Prepare and review but not limited to, preparation and review of SOPs, STMs, failure investigation and process deviation report, stability study protocol/report, instrument qualification protocol/report and analytical technical transfer protocol/report.
Interface with contract labs regarding QC sample handling and reporting.
Maintain and Ensure Raw Material Qualification is completed for new and current Raw Materials.
Ensure Annual Testing is completed per site procedures.
Assist in the implementation of R&D methods and/or analytical method optimizations, method equivalencies, validation/verification into the QC laboratory.
Excellent QMS (Agile/Oracle) skills to initiate queries and Change Control documentation submissions.
Evaluate and interpret the test results and other related technical documentation.
Assist in the implementation of LIMS system (Labware).
Upholds all elements of data integrity. Support audits (internal, customer, and regulatory) and address findings.
Other duties may be assigned as deemed appropriate by management.
PHYSICAL REQUIREMENTS:
Employees are required to wear eye protection and lab coats while in the lab area.
Work safely and follow all OSHA regulations and company safety policies and procedures.
Ability to frequently lift and/or move up to 25 lb.
Ability to occasionally lift and/or move up to 35 lb.
Ability to regularly stand, sit and walk to perform tasks.
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