Overview
Manufacturing/Quality Assurance Associate (Batch Records Review, cGMP) Jobs in Thousand Oaks, CA at Aequor
Title: Manufacturing/Quality Assurance Associate (Batch Records Review, cGMP)
Company: Aequor
Location: Thousand Oaks, CA
Job Title: Quality Assurance Senior Associate
Location: Thousand Oaks CA – 100% onsite
Duration: 12 months with possible extension
Terms: Contract W2
Description:
FULLY ONSITE AT USTO
Must be flexible as it is possible worker will start on any shift. Rotate every 6 months.
Day 6am-5pm
Swing’s 1pm-(12am)
Graves 7pm-8am
Will change on the business they are supporting
Rotate every 6 months
Will Support Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas. Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems. Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations . 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 for the Drug Substance 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.
Also, ability to make Quality based decisions in order to ensure compliance.
• Experience managing projects through to completion & meeting timelines.
• Evaluating 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.
Top 3 Must Have Skill Sets:
organizational skills
critical thinking ability
team player mindset
Day to Day Responsibilities:
On the floor support giving PQA support for Manufacturing support. Record review and approval for BRRs, Deviations and SOPs. On the floor support giving PQA support for Manufacturing support. Record review and approval for BRRs, Deviations and SOPs.
