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Quality Assurance Associate (QA-Engineering)

Holly Springs, NC 27540

Posted: 11/17/2023 Employment Type: Contract Job Category: Quality and Compliance Job Number: 592783 Is job remote?: No Country: United States

Job Description

Target PR Range: 50-67/hr
*Depending on experience

Job 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 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 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:
• Bachelor’s 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.
• 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 standards.
• 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.

Reason for request: project support for Window 7 to Windows 10 upgrade

 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Holly Springs, NC

Ready to take the next step in your career? Explore job opportunities in the bustling area around Holly Springs, North Carolina, where growth awaits at every corner. Nestled in the heart of the Tar Heel State, Holly Springs offers a perfect blend of small-town charm and big-city amenities. From its vibrant arts scene at the Holly Springs Cultural Center to the mouthwatering Southern cuisine found at local favorites like the Mason Jar Tavern, this region has something for everyone. Boasting proximity to Raleigh, Durham, and Chapel Hill, as well as being a stone's throw away from attractions like the NC Museum of Art and PNC Arena, Holly Springs provides a unique and attractive environment for professionals looking to thrive. Dive into our job listings today and discover the endless opportunities this lively area has in store for you!

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.