QC Associate II

Job Description

Job Summary:

• The Quality Control Biochemistry Associate II is responsible for contributing to key functional, tactical, strategic and operational aspects of the large molecule testing for Biochemistry group.
• This includes performing in-process, release testing, method transfer, validation testing and related activities associated with this testing.

Duties and Responsibilities:

• Associate II’s responsibilities include, but are not limited to testing pH, Appearance, Osmolality, Protein Concentration (UV, RI, and SoloVPE).
• The Associate II should possess a fundamental understanding of the Quality Systems and apply it in their daily support functions.
• Additional responsibilities include ensuring adherence to all GLP/GMP requirements, interfacing with Quality and manufacturing as applicable.
• Supporting investigations impacting the QC department.
• The Associate II should be able to work effectively within the group, within Quality and across site.
• This requires solid and robust written and verbal communication skills.

Principal Accountabilities:

Accountability Description Percent of Time:

• Performs in-process, release testing, method transfer and validation support activities/testing. Supports investigational activities including testing. 85%
• Supports QC Biochemistry operations related to business and manufacturing schedules; support of process validation initiatives. 10%
• Supports maintenance of effective laboratory systems to ensure integrity of all laboratory results. 5%
  Total 100%

Minimum Education Requirements:

• B.S. Degree (Science Preferred).

Minimum Experience Requirements:

• 2+ years of relevant experience (M.S. degree) or 3+ years of relevant experience (B.S. degree).