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The QC Analytical Analyst, under minimal supervision, is responsible for the timely completion of lot release, stability, and non-routine testing of pharmaceutical drug substances and drug products while adhering to cGMP guidelines and procedures. The Analyst works independently on assays they have mastered and performs advanced assays for multiple products. Work assignments will encompass performing and documenting activities and requires the ability to recognize deviations from approved procedures. Good record keeping, organizational, and written and verbal communication skills are essential. The Analyst is expected to demonstrate strong cGMP and compliance acumen, become a subject matter expert for regulatory inspections, and provide training and educational development of other staff.
Job Responsibility:
Performs biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines
Works independently on assays they have mastered
Develops and maintains proficiency in a broad range of test methods
Develops a technical understanding of each assay and assists with trouble shooting and laboratory investigations
Evaluates data against defined criteria/specifications
Actively applies knowledge in non-routine situations using a thorough understanding of the work processes and practices
Identifies key issues in complex situations, analyzes problems, and makes sound decisions
Assists in the revision of written procedures, method/equipment validation, and/or method transfers as assigned
Mentors and trains other analysts, including new hires and more junior analysts, in areas of expertise
Holds self and others accountable for adherence to department and company policies and practices
Maintains a safety and quality focused culture
Requirements:
1-2+ years of experience in a cGMP/GLP laboratory
1-2+ years hands-on experience in separation sciences (HPLC, UPLC, CE)
Ability to follow written instructions and to perform tasks with direct or minimal supervision
Strong leadership skills demonstrated through past work history
Proficient in Windows, Microsoft Word, Excel
Good written and verbal communication skills
Attention to detail and strong documentation skills
Ability to contribute effectively in team environments and independently
B.S./B.A. in Science (Major in Chemistry, Biology, Biochemistry)
Nice to have:
1-2+ years of Quality Control laboratory experience
1-2+ years of hands-on experience in separation sciences (HPLC, UPLC, CE)
What we offer:
Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans