Quality Assurance Associate

SGS Consulting; Charlotte (NC); On-site; USD 95,000 - 140,000; Full time

Job summary

SGS Consulting in Charlotte, NC is seeking an experienced QA professional to lead qualification and validation activities within a biotech manufacturing environment. You will provide hands-on QA support to internal staff and suppliers, ensuring compliance with GMP, FDA, EMA, and ICH guidelines.

Responsibilities include QA review and approval of commissioning/qualification/validation documents, deviations, and CAPA; coaching cross-functional teams on risk-based qualification and the application

Qualifications

• BS or MS in Biological/Physical/Chemical sciences, engineering, or equivalent with 3–5+ years QA in biologics manufacturing.
• Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities.
• Strong understanding of FDA/EMA/ICH guidelines and GMP best practices.

Responsibilities

• Provide hands-on QA support and oversight to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance.
• Provide QA review and approval for commissioning/qualification/validation documents.
• Review and approve qualification/validation deviations and support investigations and CAPA.
• Coaching site teams on GMP principles and fostering a Quality Culture.
• Author/review controlled documents (SOPs, specs, protocols, reports).
• Assist in regulatory inspections (FDA/EMA/DHHS) as needed.

Skills

QA validation

Regulatory knowledge

GMP compliance

Risk-based qualification

Analytical skills

Root cause analysis

Documentation proficiency

Team collaboration

Communication skills

Problem solving

Education

BS/MS in sciences/engineering

Job description

Job Responsibilities:

• Provide hands on QA support and oversight to internal staff and suppliers/contractors to ensure compliance with local and global quality standards, regulatory requirements, and industry guidance.
• Provide QA review and approval for commissioning/qualification/validation documents.
• Provide QA review and approval of qualification and validation deviations and discrepancies and support investigation and corrective actions.
• Work collaboratively with other site functions to instill a ‘Quality Culture’ by coaching in the application of GMP principles including the underlying rationale of those principles.
• Author, review and approved controlled documents for the Quality organization and other GMP functional areas including SOPs, specifications, protocols, and reports.
• Assist in the preparation and hosting of regulatory (e.g. FDA, EMA, DHHS, etc.) inspections as needed.

Skills:

• Strong knowledge of risk-based approach to qualification and validation activities in a Biotech Quality environment.
• Experience with qualification/validation of process equipment, analytical instruments, clean utilities, automation, sterile filling, and clean facilities.
• Strong understanding of FDA, EMA, local regulations and guidelines, ICH guidelines, and industry best practices.
• Successful history working in a fast-paced team environment, meeting deadlines, and prioritization of work from multiple projects.
• Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.
• Excellent problem-solving skills and experience with root cause investigations and CAPA determination.
• Advanced computer skills.
• Off hours coverage and flexibility may be required.

Education/Experience:

• B.S. degree in Biological/Physical/Chemical sciences, engineering, or equivalent focus of study and 3-5+ years of experience or M.S. degree and 1-3+ years of experience in a QA function in a biologics manufacturing facility