Quality Associate II, Contract

Quality Associate II, Contract Irvine, CA Job Details Full-time $31 - $34 an hour 6 days ago Benefits Health insurance Dental insurance Vision insurance Qualifications Quality control corrective actions Biology Bachelor's degree in biological science CGMP Document review (document control) Sample preparation Calibration Pharmaceutical regulatory compliance SAP Laboratory information management systems Corrective and preventive actions (CAPA) Mid-level Manufacturing standard operating procedures Quality assurance Bachelor's degree Quality control documentation Batch records Chemistry Data collection Quality assurance within manufacturing 2 years Bachelor's degree in chemistry Full Job Description BioPhase specializes in recruiting top talented professionals for the Orange County scientific community. We are currently looking for a Quality Associate II, Contract to work for a leading biopharmaceutical company in Orange County.

Pay :

$31-34/hour

Schedule :

M-F, 8am - 5pm / some

OT Responsibilities:

Prepare in-process samples for submission to the Quality Control laboratory. Support handling of GMP events and initiation of deviation investigations. Read, understand, and follow SOP's and complies with cGMP. Provide Quality support to Manufacturing personnel on the floor for compounding and QA- in-process checks. Perform line clearance verification, sterilization chart review, scale calibration verification, and QA in-process checks Review executed batch records for completeness, accuracy and compliance with approved procedures and Good Documentation Practices (GDP) and resolve discrepancies with manufacturing operators or supervisors. Use computerized system such as SAP, LIMS, and TrackWise for data collection and batch record review. Participate in deviation investigation and CAPA implementation. Initiate Certificate of Conformance and prepare executed batch records for product release in a timely manner to meet compliance requirements and business needs. Other duties as assigned by management.

Requirements:

Bachelor's degree in a biological science, chemistry, or related science field. Minimum of 2 years of quality experience in the pharmaceutical / biopharmaceutical industry with experience in batch record review and product release.

Job Type:

Full-time Pay:

$31.00 - $34.00 per hour

Benefits:

Dental insurance Health insurance Vision insurance

Education:

Bachelor's (Required)

Experience:

Quality Assurance:

2 years (Required)

CGMP:

2 years (Required)

Work Location:

In person