"Alerted.org

QA Lead Technical Operations - CAPA

Job Location

Devens, MA

Workspace

On-site position (no remote or hybrid options)

Target Hiring Date

July 14, 2025

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.

Requirements

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 the Role

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.

About the Company

Join Sokol GxP Services – Where Innovation Meets Integrity!

Join Sokol GxP Services, where we partner with leading pharmaceutical and biotech companies to provide exceptional Commissioning, Qualification, and Validation (CQV) services. We are committed to fostering diversity, empowering local talent, and building strong community connections to bring the best-qualified candidates to our clients in the Summit, NJ area. Our inclusive and collaborative culture promotes growth and innovation.

Let’s shape the future of life sciences together!

All applicants will receive an acknowledgement that their application has been received within 2-3 weeks from the from the date of receipt.

Equal Opportunity Employer Statement:

Sokol GxP Services is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

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.