What are the responsibilities and job description for the QA Lead Technical Operations - CAPA position at SOKOL GxP Services?
Working Schedule Mon - Fri, 8:30AM – 5PM.
Effective Date: 14JUL2025
FLSA Classification: FT/PT | Non-Exempt/Exempt
Work authorization:
Applicants must have the legal right to work in the United States without requiring sponsorship.
Corp-to-Corp (C2C) arrangements are not accepted.
DUTIES AND RESPONSIBILITIES:
- Provide QA support to the Devens site and QA Manager by reviewing and approving investigations and corrective actions (CAPAs).
- Make decisions on non-conformances using a solid understanding of Quality Systems and regulatory requirements.
- Review and approve documents related to Quality, Quality Control, Validation, and Automation.
- Review and approve Standard Operating Procedures (SOPs).
- Review and approve validation documents including risk assessments, protocols, test scripts, and summary reports.
- Review and approve change control proposals and ensure deliverables meet internal and regulatory standards.
- Provide guidance and coaching to other teams on investigations, CAPAs, risk assessments, and validation processes.
- Analyze complex data and make well-informed decisions with minimal supervision.
- Will regularly interact with Reporting Manager, and sometimes – with different departments.
EDUCATION:
- Knowledge of science generally attained through studies resulting in a B.S.; in Biological science, Engineering, biochemistry, or related discipline, or its equivalent is preferred.
QUALIFICATIONS:
- Advanced Level of relevant experience in a GMP, GCP, or GXP with at least 8 years focused on product quality. Preferred Active member of ASQ or ISPE.
- Prior experience of QC equipment Qualification and some project management experience.
- Knowledge of biotech, bulk drug substance or finished product manufacturing, medical device analytical testing ishighly desirable.
- Extensive knowledge of US and EU cGMP regulations and guidance and GAMP 5.
- Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise,Veeva Vault and electronic, or paper-based batch records desirable.
- Excellent Technical writing and oral communication skills are required.
- Background in problem solving
- Knowledge of Data integrity principles
- Proven attention to details
- Comfortable working in an FDA regulated environment.
ABOUT US:
SOKOL GxP Services is a rapidly expanding provider of Commissioning, Qualification, and Validation (CQV), Computer System Validation (CSV), and a full suite of GxP services tailored to the pharmaceutical, biotechnology, cell therapy, and medical device industries. Our mission is to help clients achieve regulatory compliance while upholding the highest standards of product quality and safety.
Our customized solutions are designed to guide clients through complex regulatory landscapes, enhancing the efficiency and compliance of their GxP processes. At SOKOL, we’re committed to empowering our clients with the expertise and precision needed to confidently meet and exceed industry standards.
Crafting GxP Excellence!
All applicants will receive an acknowledgement that their application has been received within 2-3 weeks from the from the date of receipt.
By submitting your application and resume, you consent to have your information retained in our repository for six months. This allows us to consider you for future opportunities that may align more closely with your skills and qualifications. If a suitable position becomes available, we will contact you directly.
Equal Opportunity Employer Statement:
SOKOL GxP Services is an equal opportunity employer. All qualified applicants will be considered without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity, or any other characteristic protected by law.