Description:

The Sr. Associate Quality Assurance position supports Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities and Engineering staff in the execution of their processes, procedures, and use of quality systems.

Ideal candidate: They will be working on the manufacturing floor. Detail Oriented, Team player and Quality Experience.

Duties include but are not limited to:

Purposeful presence on the manufacturing floor, inc. Inspection support, ASP and QA assessments,

Electronic batch record review,

SOP revision approval,

Maximo System - Work order, job plan approvals,

Quality support and approval of minor deviations and CAPA records.

MES revisions and approvals

Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area quality for the Drug Product Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.

Preferred Qualifications:

Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field

Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices

Experience managing projects through to completion meeting timelines.

Ability to evaluate documentation and operations according to company procedures.

Experience working with Quality Systems

Strong organizational skills and ability to manage multiple tasks at one time

Effective communication skills (both written and verbal)

Demonstrated ability to work as both a team player and independently

Display leadership attributes and drive improvement initiatives

Solid understanding and application of aseptic behaviors and principles

Basic Qualifications

Master degree OR Bachelor degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Top Must Have Skill Sets:

Detail Oriented, Team player and Quality Experience.