Quality Control Analyst II Position Description
- Provide analytical support for product complaint investigations
- Providing analytical support during the technology transfer and qualification of new manufacturing sites
- Managing contract testing sites (both domestic and international) to support testing of the IPC, release and stability samples
- Performing data review, data tracking and trending to support release and stability testing of drug products
- Supporting regulatory submissions by providing batch analysis and stability testing data
- Representing QC business processes and needs within the department and at cross functional forums
- Independently support a range of assigned projects, routine, non-routine, and investigative QC laboratory analytical testing pertaining to, commercial release testing, process validation, stability, and performance trending to support drug substance and drug product and/or finished goods
- Support quality control CMC regulatory activities
- Demonstrates an understanding of company priorities, objectives and project timelines. This includes understanding how QC activities affect the business.
- Applies scientific judgment to perform investigations of Out of Spec (OOS) and Atypical results. Works with external service providers on the timely resolution of deviations.
- Collaborates with Regulatory Affairs on preparation of submission documents, responses to questions from Health Authorities, and updates on stability and batch analysis data.
- Supports and oversees testing for process validation activities, as applicable.
- Authors stability protocols and reports, validation documentation, change controls and investigations to maintain compliance.
- Demonstrates good understanding of analytical methodology.
- Ensures that complete, accurate and valid quality testing documentation is received by Company.
- Meets with multifunctional groups on a regular basis to discuss individual projects and departmental goals.
- Actively engage fellow analysts and specialists as a peer coach, offer/seek perspective and guidance
- Generate notification forms indicating investigation activities such as retain inspection, and analytical testing as appropriate for Product Complaints
- Retain Testing at Contract Manufacturers/Laboratories
- May perform other duties as assigned.
- Bachelors or Masters Degree in Life Sciences (chemistry or biology) with relevant laboratory coursework and 3-6 years of experience in Pharmaceutical/Biotechnology field
- Must have good understanding of a variety of analytical techniques such as HPLC, GC, CE-SDS, bioassay and icIEF. Experience in cell based assays and oral solid dosage is a plus.
- Must have good understanding of cGMPs and quality systems.
- Ability to handle multiple tasks concurrently, and in a timely fashion, organizational skills and attention to details.
- Must have good communication and interpersonal skills and ability to work effectively and efficiently in a team environment.
- Must be computer literate and able to navigate, conduct searches, and complete online forms for the purposes of training, performance management, and self service applications.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.