BioSpace · 1 week ago
Quality Control Laboratory Analyst
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Responsibilities
Perform analytical testing, interpret results, and document actions and results using proper documentation practices.
Participate in analytical method transfers and perform method verifications/validations.
Notify management of OOS, OOT, or atypical results on the day of discovery with the appropriate level of urgency.
Lead and/or participate in laboratory investigations.
Ability to complete HPLC analysis with minimal supervision. Experience with Empower software, and PDA or QDa detection is a plus.
Maintain LIMS data.
Contribute to and promote a safety culture by adhering to established safety procedures, engineering controls, and appropriate PPE.
Maintain a clean and organized work environment in accordance with 6S lean principles.
Inform management of continuous improvement and opportunities.
Lead and/or participate in 6S and OPEX initiatives.
Ability to work independently or in a team setting effectively.
Complete chemical inventory and ordering supplies as required.
Conduct other duties as required by management.
Qualification
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Required
Bachelor’s degree in a scientific discipline with a minimum of 5 years’ experience working in a regulated laboratory environment.
Proficiency with LIMS software, analytical data acquisition software, Microsoft Office® applications including Excel, Word, and PowerPoint.
Ability to multi-task and change priorities in a fast-paced environment.
Self-motivated and willingness to learn and help others.
Working knowledge of relevant FDA and ICH guidelines and USP requirements preferred.
Experience with the following: Wet chemistry testing by USP methods, pH, conductivity, atomic absorption and loss on drying.
Proficient in HPLC analysis.
Prepare and/or review technical documents such as protocols, reports, SOPs and testing procedures.
Experience with GMP and working knowledge of data integrity.
Familiarity with analytical method transfers, method verifications and validations.
Company
BioSpace
BioSpace is the leading online community for industry news and careers for life science professionals.
Funding
Current Stage
Growth StageTotal Funding
$10M2000-08-24Series B· $10M
Recent News
2024-05-31
2024-05-05
2024-04-06
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