QA Compliance Specialist I

Anika Therapeutics • Bedford, MA

83d

About The Position

The Quality Assurance (QA) Compliance Specialist I performs compliance activities in support of production and engineering, ensuring all activities are performed according to internal Quality System requirements, cGMP, FDA, and ISO 13485 standards. Areas of responsibilities include receipt and review of documents such as charts, logs, batch records, and approval of incoming materials for release. The position will provide floor support to production departments, including line clearances, in-process checks, and assistance with investigations. The QA Compliance Specialist I performs quarterly audits, supports internal audits, and participates in customer and regulatory audits as part of the Audit Team.

Requirements

• Bachelor's Degree or equivalent experience
• Medical device quality system management experience or an acceptable combination of education and experience will be considered. Internship experience may be considered.
• Knowledge of GMP, FDA, ISO requirements.
• Requires computer competence, including experience with database and Microsoft Office.
• Excellent written and verbal communication skills.

Nice To Haves

• Experience working in a GMP/ISO environment.
• Good presentation and organization skills.
• Attention to details.
• Capable of executing tasks per defined policies and procedures to resolve routine issues.

Responsibilities

• Review and approve supplemental logs, charts and other documents in support of cGMP Operations.
• Review batch records for accuracy and completion prior to final release of product.
• Perform product releases specifically fills and intermediates lots.
• Coordinate product releases with distributors and customers as needed.
• Review and approve incoming materials for release.
• Provide quality assurance support of investigations including: nonconformance and root cause analysis.
• Perform quarterly walkthrough audits of manufacturing and packaging, complete audit activities as assigned.
• Issue, review and reconcile batch records as needed.
• Assist in the maintenance of the Quality System.
• Participate in project teams and perform other related duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree