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 plansHoliday PayTeladoc (online care)Referral Bonus IncentiveAnd More!Quality Assurance Specialist Details:
Contract position$45.00 /hourFirst 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
#IJ #ENG1
Apply to this Job Log In OR Create an Account