Quality Assurance Associate (QA-Engineering)
475 Green Oaks Parkway Holly Springs, NC 27540 US
*Depending on experience
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
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