Have Copilot read job descriptions and extract out key info you want to know. Click "Analyze All" to try it out. Click on the Copilot's gear icon to customize the prompt.

Quality Assurance Associate (QA-Engineering)

9bjdnw2mlhip8doaz2t0q9w4wphk960418ms6mtfp5oxvgnr76bfafpnr8c62y27 · 30+ days ago

Holly Springs, NC, US

Negotiable

Full-time

Continue

By pressing the button above, you agree to our Terms and Privacy Policy, and agree to receive email job alerts. You can unsubscribe anytime.

Quality Assurance Associate (QA-Engineering)

Location: Holly Springs, NC/Remote
Duration: 15 weeks

Description:
The contractor will be a member of the QA-Engineering team, supporting QA Engineering activities and programs at the Holly Springs Cell Culture manufacturing facility.

The QA-Engineering contractor applies Client quality principles related to equipment qualification, computer system validation (e-compliance), cleaning, method, and process validation. Utilizes integrated commissioning and qualification principles to ensure compliance with equipment and system qualification. Supports the development and maintenance of quality procedures and systems related to Quality Assurance oversight. Provides technical support for the US FCC site in all cGMP compliance-related matters, including assurance that all aspects comply with cGMPs, legal, and regulatory requirements.

Ensures that qualification, validation, and technical protocols, and reports comply with site SOPs. Provides review and approval of related documents.
Provides QA oversight to equipment qualification, computer system validation (e-compliance), method, process, and cleaning validation including revalidation and re-evaluation.
Provides validation documentation lifecycle oversight.
Utilizes data analysis skills and statistical tools to interpret results in support of acceptance criteria and regulatory requirements.
Interfaces with customers and partners on quality-related issues, participates as the QA representative on multi-functional continuous improvement teams and ensures efficient and timely project support.
Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance-related matters are provided to the site. In addition, ensures Good Engineering Practices are followed according to GAMP, ISPE, and Client standards.
The QA-Engineering contractor will have QA oversight on validation deliverables in QC, Bulk Manufacturing, and Fill Finish collaborating with CQV (Commissioning Qualification and Validation), MS&T (Manufacturing Science and Technology), AS&T (Analytical Science and Technology), QC (Quality Control), Manufacturing, and Engineering.

Minimum Required Qualifications:
Bachelors degree in science or engineering discipline preferred or equivalent experience in biotech or pharmaceutical industry.
5+ years experience in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry or equivalent.
Incumbent should possess a solid understanding of computer system validation and equipment qualification.
Experience in method, cleaning and process validation and associated deliverables including international regulatory and legislative requirements is preferred.
Team player developing relationships with key individuals in the work teams, offering assistance and sharing resources with other team members.
Experience with e-Compliance/computer validation preferably in a GMP regulated environment within the pharmaceutical industry. •

Last updated on Nov 14, 2023

About the company

9bjdnw2mlhip8doaz2t0q9w4wphk960418ms6mtfp5oxvgnr76bfafpnr8c62y27

More jobs at 9bjdnw2mlhip8doaz2t0q9w4wphk960418ms6mtfp5oxvgnr76bfafpnr8c62y27

Analyze All

More jobs like this

Analyze All

For job seekers

Job searchSearch millions of jobs

LaunchpadNew

Resume to business

Cover Letter StudioGenerate a cover letter

Add to ChatGPTFind and discuss jobs

For employers and recruiters

Resume ScreenerOrganize and rank candidates

Talent PipelinePre-order

Source top talent

Promote a jobReach more candidates

For everyone

Referral programEarn 30% commission

Get mobile appBrowse anywhere

Jobs API

Become a partner

Developed by Blake and Linh in the US and Vietnam.

We're interested in hearing what you like and don't like! Live chat with our founder or join our Discord

Changelog

🚀 LaunchpadNov 27

Create a site and sell services based on your CV.

🔥 Job search dashboardNov 13

Revamped job search UI with a sortable grid, live filtering, bookmarks, and application tracking.

🫡 Cover letter instructionsSep 27

New Studio settings give you control over AI output.

✨ Cover Letter StudioAug 9

Automatically generate cover letters for any job.

🎯 Suggested filtersAug 6

Copilot suggests additional filters above the results.

⚡️ Quick applicationsAug 2

Apply to jobs using info from your CV. Initial coverage of ~200k jobs in Spain, Germany, Austria, Switzerland, France, and the Netherlands.

🧠 Job AnalysisJul 12

Have Copilot read job descriptions and extract out key info you want to know. Click "Analyze All" to try it out. Click on the Copilot's gear icon to customize the prompt.