Quality Assurance Specialist

Category: Professional
Location: Torrance, CA 90501
Pay: $45.00 Hourly
Posted: 2 weeks ago
Status: Open

Description

Quality Assurance Specialist


Great Opportunity!


Company Profile

A leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides.


What's in it for you?

Elwood Professional associates are eligible for a comprehensive and competitive benefits package plus an exclusive savings program, including:

  • Medical/Vision/Dental/Rx plans
  • Holiday Pay
  • Teladoc (online care)
  • Referral Bonus Incentive
  • And More!

Quality Assurance Specialist Details:

  • Contract position
  • $45.00 /hour
  • First Shift (Monday through Friday)

• Individuals in this position review and process assigned GMP documents, provide cGMP guidance to other departments, and provide support to customers and regulatory audits.

• Additionally, to manage (i.e. reconcile, issue, and maintain) GMP documents and records and, to provide support in document management electronic systems (e.g. Master Control)

• Performs production room, dispensary and shipment clearance verifications, as required

• Revises established standard operating procedures (SOPs) as well as other GMP documents (e.g. stability protocols, raw material specifications, EM trend reports) as assigned.

• Manages GMP documentation and their workflows as required by the department

• Verify scans of BPRs, chromatograms, etc. for accuracy and ensure documents are boxed, labeled correctly for archiving

• Provides support to regulatory, customer, and internal audits

• Drives continuous improvements and represents QA in process improvement project teams

• Implements and maintains Quality Management System.

• Scan, verify and archive GMP records (internal and external).

 


Quality Assurance Specialist Qualifications:

• Bachelor's degree in a science related field and a minimum of 3 years’ experience in a GMP manufacturing setting or Associates in a science related field and a minimum of 5 years' experience in the GMP manufacturing setting

• 3-5 years’ experience in Quality Assurance and/or Quality Control, internal auditing as well as working with regulatory agencies

• 3-5 years’ experience working in ISO 7 and ISO 8 control environment and support real time batch record review

• Ability to review scans of BPRs and chromatograms with high accuracy

• Knowledge of cGMP and FDA regulations and guidance(s)

• Knowledge of Quality Management Systems, GxP



We are an Equal Opportunity Employer and celebrate diversity at all levels of our organization.


Our commitment to you: to be Kind, Helpful, Respectful, Honest and Committed To Finding You Work.


How to Apply:

Email, call, or text us today! Feel free to apply online at www.elwoodjobs.com!


Daniel Oliver

5230 Carroll Canyon Road

San Diego, CA 92121

(619) 894-8648 ext.

daniel.oliver@elwoodprofessional.com



Qualifications

*See above for qualifications

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