Quality Assurance Engineer
This is for a manufacturing QA role and NOT for software.
Job Description for the Quality Assurance Lead (QA Lead)
- Support regulatory/customer inspections, audits, and investigations, collaborating with sales, customer service, and co-manufacturers on product complaints, trends, and third-party adverse reaction reports.
- Oversee the review, approval, and release of raw materials, bulk, and finished products, ensuring compliance with internal and customer specifications.
- Manage stability programs, deviation logs, CAPA processes, and supplier qualifications, ensuring all records (e.g., Certificates of Analysis, Finished Product Specifications) are accurately maintained.
- Lead root cause analysis, corrective actions, and continuous process improvement efforts across the department.
- Maintain and report on quality metrics, scorecards, and complaint registries, ensuring timely escalation of critical issues to senior management.
- Develop, review, and update SOPs, provide staff training on quality procedures, and ensure full regulatory compliance (cGMP, FSMA, FDA, etc.) and relevant certifications (ASQ, PCQI).
Qualifications, Experience, and Required Attributes
- Bachelor’s degree in Science or related field, with 5 years of experience in a GMP environment (food, dietary supplements, pharmaceuticals preferred).
- Training in cGMP, FSMA, and other relevant industry regulations.
- Preferred certifications: ASQ, PCQI, etc.
- Proficiency in Microsoft Office, with advanced skills in Excel and data analysis.
- Strong analytical, mathematical, and spreadsheet skills.
- Ability to follow and enforce written and verbal policies and procedures.
- Exceptional verbal and written communication skills, with a high degree of professionalism in interacting with internal teams, customers, and partners.
- Strong interpersonal skills, attention to detail, and organizational proficiency.
- Self-motivated, with the ability to work both independently and collaboratively in a fast-paced, dynamic environment.
- Creative problem-solving skills and the ability to adapt to changing priorities.
Would you like to know more about our new opportunity as a QA Lead? For immediate consideration, please send your resume directly to Suresh Gaddala by emailing him directly at [email protected] OR giving him a call directly at 954-715-4788 You can also apply online while viewing all open jobs at . ARC Group is a Forbes-ranked top 20 recruiting and executive search firm working with clients nationwide to recruit the highest quality technical resources. We have achieved this by understanding both our candidate's and clients' needs and goals and serving both with integrity and a shared desire to succeed. ARC Group is proud to be an equal-opportunity workplace dedicated to pursuing and hiring a diverse workforce. We are a no-fee agency for candidates.
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