LQA Analyst II

Nexus employees earn 4 weeks' vacation per year, and our benefits start on day 1!
Title: LQA (Lab Quality Assurance) Analyst II
Full Time
Location: Lincolnshire, IL
Our Company
Nexus Pharmaceuticals, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they're needed most.
Summary
The LQA Analyst II will focus on Analytical Data Review and must be familiar with applicable cGMP regulations and systems and can make decisions based those requirements. This individual will function as a primary role within the Quality Assurance department and must demonstrate excellent communication, critical thinking, and organizational skills.
Responsibilities:

• Audit data packages for scientific merit, GDP, and compliance to internal procedures
• Data review including but not limited to analytical testing data supporting product release, incoming material testing, stability studies and qualification, validation and/or verification related studies and laboratory equipment logbooks
• Review Certificate of Analysis and Certificate of Testing for accuracy and compliance
• Participate in change control process as necessary to maintain document audit readiness
• Participate in Corrective and Preventive Action (CAPA) plan actions as means of continuous improvement
• Responsible for the timely closure of assigned quality records
• Participates in inspection readiness activities and assists in inspections by regulatory authorities (FDA/DEA)
• Track quality records and provide metrics to for management review
• Identify improvements/new procedures/compliance gaps based on applicable regulations for GMP operations
• Review logbooks for accuracy, completeness, compliance to company standard operating procedures and regulatory guidelines/regulations
• Maintain and issue logbooks to the laboratory as needed
• Maintain, issue, and reconcile serialized forms
• Perform internal audits according to schedule to identify areas of concern and/or process improvements based on current Federal Regulations
• Utilize knowledge of good documentation practices and good laboratory practices daily
• Provide quality support to laboratory material receipt, controlled substance program, pest control, calibration, stability, and other laboratory needs
• Other duties as assigned

Skills and Abilities:

• Specific skill set: quality minded, critical thinking, technical writing, problem solving, experience in investigative techniques, highly detail oriented, and highly organized
• Ability to communicate clearly and concisely when conveying information, summarizing facts, asking questions, etc.
• Must be able to work independently
• Strong organizational skills

Education or experience:

• BS science degree, preferably in Chemistry or Biochemistry
• Minimum of 1 years of applicable cGMP industry experience. Analytical laboratory, QC laboratory, Manufacturing, QA experience may be considered.
• Applicable candidate must have relevant lab experience within either the pharmaceutical or biopharmaceutical industry to qualify
• Requires familiarity with HPLC/GC data interpretation

Travel Requirements:

• 0-5% travel required for this role (domestic and international)

Physical Requirements:

• Lifting requirements less than 50 pounds
• Sitting 85% of day
• Office and laboratory environment

Level of Proficiency:

• Must be able to work independently
• Strong organizational skills

DISCLAIMER: The list under Role Responsibilities are not exhaustive, but are merely the most accurate lists for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change.
EEOC Statement: Nexus is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Nexus participates in E-Verify.