QA Specialist II
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?
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!
QA Specialist II Details:
Contract position$38.00 to $45.00 /hourFirst Shift (Monday through Friday)• The QA Specialist II performs the day-to-day activities of the Quality Assurance department to ensure drug substances manufactured comply with FDA and international regulatory requirements for research, pre-clinical, clinical, and commercial purposes.
• Review batch records in a timely manner and with high accuracy.
• Perform production room, dispensary and shipment clearance verifications
• Revise established standard operating procedures (SOPs) as well as other GMP documents (e.g. stability protocols, raw material specifications, EM trend reports) as assigned.
• Manage GMP documentation and their workflows as required by the department
• Coordinate, review and approve quality events • Provide support for regulatory, customer, and internal audits
• Drive 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).
• Represent QA in project teams (e.g. – harmonization of systems/processes across other facilities, implementation of new systems/processes)
QA Specialist II Qualifications:
• Bachelor’s degree in a scientific field and a minimum of 3 years’ experience in a GMP manufacturing setting and 4-6 years’ experience in a GMP manufacturing QA environment, experience with GMP document control, validation, qualification and calibration
• 4-6 years’ experience in internal auditing as well as working with regulatory agencies
• 4-6 years’ experience working in ISO 7 and ISO 8 control environment
• Knowledge of cGMP and FDA regulations and guidance
• Knowledge of Quality Management Systems • Knowledge of GxP
• Proficient computer knowledge, including Microsoft Word, Excel, and PowerPoint
Applicant may be subject to a background check*A conviction record will not necessarily prevent you from being employed. You will be required to complete and submit a questionnaire. We will consider your age at the time of the offense, when the offense occurred, the seriousness and the nature of the offense, as well as any rehabilitation to determine your employability.
We are an Equal Opportunity Employer and celebrate diversity at all levels of our organization.
Our commitment to you: Real People. Fast job offers. No Robots.
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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