QC Analyst II

Job Description

Job Summary

Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.

Responsibilities

Provide timely analyses to support manufacturing and stability. This includes routine analyses of raw materials, in process and release of commercial product or clinical supplies

Independently perform assays under GMP, maintaining data integrity and ensuring compliance with company SOPs and specifications

Provide accurate, written documentation of all work, including detailed observations and conclusions.

Under general guidance, participate in laboratory investigations

Independently operate, maintain and troubleshoot laboratory instrumentation and equipment in a safe working environment

Skills required

Well-organized, capable of multi-tasking, and able to collaborate with individuals in a matrix environment

Extensive hands-on experience performing relevant analytical techniques (HPLC, GC, FTIR). Experience with EMPOWER a plus

Must have excellent data analysis skills with attention to detail and interpretation of results with a focus on problem solving

Excellent written, oral communication skills, and experience with computer software such as WORD, EXCEL, etc.

Knowledge of validation requirements for QC methods and regulatory guidelines

Education and Experience Minimum Requirements

Bachelor’s Degree in science or related field

2-5 years relevant experience in a cGMP pharmaceutical QC environment, or at least 1 year with a Master’s degree

Physical Requirements

Prolonged periods of sitting at a desk and working on a computer

Potentially prolonged periods standing

Must be able to lift up to 15 pounds at times

Must be willing to travel

Compensation

The base salary for this role starts at $41/hour. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, and relevant education or training. Our compensation package also includes diverse health and other benefits and an annual target bonus for full-time positions.

Full-time