Sr QC Analyst

Overview

Onsite from Monday to Friday

Senior Analyst, Quality Control Analytical

SUMMARY

The QC Analytical Senior 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 Senior 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 Senior 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.

• Performs, under minimal supervision, 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

• 3+ years of experience in a cGMP/GLP laboratory
• 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
• Use of a computer: e.g., 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

• 3-5 years of Quality Control laboratory experience
• 3-5 years of hands-on experience in separation sciences (HPLC, UPLC, CE)

B.S./B.A. in Science (Major in Chemistry, Biology, Biochemistry).

• Waters HPLC
• Waters UPLC
• Dionex HPLC
• Sciex PA800
• Protein Simple iCE3
• UV/VIS Spectrophotometer
• pH Meter

• Internal and External Quality Assurance
• Manufacturing
• Scheduling and Sample Management
• Stability and Critical Reagent Management

• Not applicable to this position

• Name:
  Physical Location Country Code — Value: US
• Name:
  Legal Employer/Legal Entity — Value:
  *** Pharma Inc
• Name:
  Email Needed — Value:
  Yes
• Name:
  Assignment Category — Value:
  Not Applicable
• Name:
  Work Style — Value:
  Onsite
• Name:
  Worker Category — Value:
  Staff Augmentation
• Name:
  Badge Details — Value:
  Yes
• Name:
  Laptop Needed — Value:
  Yes

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.