What are the responsibilities and job description for the QC Analyst II position at Revance?
JOB SUMMARY
Revance (Nasdaq: RVNC), is a commercial-stage biotechnology company focused on innovative aesthetic, therapeutic, and financial technology offerings, setting a new standard in healthcare.
Revance is setting the new standard for our clients through our disruptive products and for our employees through our industry-leading benefits that promote financial and physical health & well-being for all employees. The anticipated base salary for candidates for this open role is $77,000 to $100,100. The final salary offered to a successful candidate will be dependent upon factors that may include but are not limited to the type and length of experience within the job type and length of experience within the industry, education, and geographic location within the United States.
The QC Analyst II of analytical team will be responsible for testing of in-process, lot release and stability samples for various commercial and clinical drug products. Author and revise SOPs, deviations, CRs and LIRs. Areas of responsibility include but are not limited to testing samples for Appearance, pH, UV and water content, ELISA, western blot and SDS-PAGE as needed. Actively participate in group and project teamwork. Support in preparing the lab documentation and lab readiness for Health Authority Inspection.
ESSENTIAL DUTIES
- Perform routine and non-routine release, in-process and stability testing for drug substance, drug product, and other critical reagents and documentation under cGMP.
- Perform Analytical assays such as ELISA, SDS-PAGE, Western Blot, Water Content, UV, Appearance, and pH
- Author quality records such as Deviation, Lab Investigations, CAPA, Change Control including leading thorough and timely investigation and/or implementation activities.
- Author/ revise SOPs.
- Review of laboratory records generated in support of QC testing including procedures, methods, audit trails and other controlled documents.
- Compile and review data to ensure accuracy and regulatory compliance.
- Support sample receiving, shipment to contract lab and inventory of sample.
- Work collaboratively with Manufacturing, QA and Regulatory to support CMC analytical deliverables.
EDUCATION
Minimum Required:
- Bachelor of Science in related Sciences
EXPERIENCE
Minimum Required:
- 2-4 years in a Quality Control laboratory environment (GMP environment preferred)
- Experience with a wide range of analytical techniques such as ELISA, SDS-PAGE, Western Blot, Karl Fisher, UV, pH and Appearance
COMPETENCIES
Key Competencies:
- Integrity, Trust, Ethics, Values
- Results oriented
- Strategic Skills
- Organizing/Priority Setting
- Business Acumen
- Planning
- Decision Quality
- Customer focused
- Conflict Management
- Interpersonal Savvy
- Negotiating
- Problem Solving
- Listening & Approachability
- Partnering
WORK ENVIRONMENT & PHYSICAL DEMANDS
This section of the job description is required by the American with Disability Act, (ADA). The ADA requires that job descriptions reflect the physical and mental demands required to effectively perform the essential duties of the job. The ADA prohibits employers from discriminating against a "qualified individual with a disability" in all aspects of the employment relationship. A "qualified individual with a disability" is "an individual who meets the education, experience, skill, and other job-related requirements of a position held or desired, and who, with reasonable accommodation, can perform the essential functions of a specified job."
- Prolonged periods of sitting at a desk and working on a computer
- Must be able to lift up to 10 pounds at times
We are an equal opportunity employer. We are a company where diverse backgrounds, experiences and viewpoints are valued. Revance does not discriminate in practices or employment opportunities on the basis of an individual's race, color, national or ethnic origin, religion, age, sex, gender, sexual orientation, marital status, veteran status, disability, or any other prohibited category set forth in federal or state regulations.
Salary : $77,000 - $100,100