QA Compliance Lead

Integrated Resources Inc.; Marlborough (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading company specializing in strategic workforce solutions is seeking a Quality Assurance professional in Marlborough, Massachusetts. The role involves developing quality systems, ensuring compliance with FDA regulations, and supporting the quality assurance processes. Candidates with a Bachelor's degree and extensive experience in regulated industries are encouraged to apply. This position offers a great opportunity to contribute to product quality and safety while working with a dedicated team.

Qualifications

• Minimum 5 years work experience required.
• At least 3 years in a regulated industry.
• Knowledge of FDA regulatory requirements essential.

Responsibilities

• Develop and maintain quality systems and procedures.
• Assist in audit preparations and compliance.
• Manage product approval and compliance documentation.

Skills

Proficiency with MS Office

Understanding of drug or Pharma QMS

Education

Bachelor's degree

Tools

Lean Manufacturing

Six Sigma

Job description

IRI believes in commitment, integrity, and strategic workforce solutions.

Integrated Resources, Inc., is led by a seasoned team with decades of industry experience. We deliver strategic workforce solutions that help manage talent and business more efficiently and effectively. Since 1996, IRI has attracted and retained key professionals, expanding into new sectors and experiencing steady growth.

We focus on finding qualified professionals in our specialty areas. Our partner-employers trust us to match the right candidates with their needs. By exceeding expectations, we build long-term partnerships based on performance and integrity.

Our team provides tailored solutions for each client, aligning skills and cultures for mutual success. At IRI, our success is linked to our clients' success.

Job Description

• Participate in developing and maintaining quality systems, processes, and procedures to ensure product quality and safety.
• Assist the quality assurance site manager in preparing for audits and implementing corrective actions for non-conformities.
• Support risk management throughout the product lifecycle and provide senior management with key data to inform decisions.
• Support the development and maintenance of product approval, clearance, and licensing documentation as required by global regulatory agencies.
• Ensure 100% quality and regulatory compliance according to documented procedures.
• Communicate and implement strategies to ensure compliance.
• Review batch records supporting the disposition of bulk drug substances.
• Review equipment validation protocols and reports.
• Support compliance in raw material and solution release, including review of specifications and documentation.
• Manage the release of single-use disposable products, including label reconciliation.
• Review temperature charts and related documentation for excursions.
• Update label issuance and reconciliation processes.

QA Documentation Support:

• Issue batch records and track logs, lab notebooks, and SOP binders.
• Scan and file excursion documents and batch-related documents for release support.
• Develop process improvement plans using tools like Six Sigma, Lean Manufacturing, SPC, DOE, etc.

Qualifications

• Bachelor's degree or minimum 5 years of work experience.
• At least 3 years of experience in a regulated industry.
• Understanding of drug or Pharma QMS and regulatory requirements, including FDA CFR 21 210 and 211.
• Proficiency with MS Office, including Word, Excel, PowerPoint, and databases.

Additional Information

Regards,
Monil Patel
Technical Recruiter
Integrated Resources, Inc
[phone] Ext. 338
[e-mail]