Summary of Primary Responsibilities:
The Quality Assurance (QA) Compliance Specialist I performs compliance activities in support of production, 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 to include line clearances, in-process checks and assistance with investigations. The QA Compliance Specialist I performs quarterly audits support internal audits and participates in customer and regulatory audits as part of the Audit Team.
Strategic Focus Area:
Effectively collaborates with internal colleagues to meet corporate objectives and drive business results. Demonstrates business and regulatory knowledge.
Specific 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.
Job Complexity:
Assignments are defined by objective and required outcome. Exercises judgment within defined parameters and policies; expected to propose practice and policy improvements. Job requires maintenance of up to date knowledge of all applicable international regulation and regulatory guidance.
Supervisor Responsibilities:
None
Required Qualifications:
- 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.
- Desired Experience, Knowledge, and Skills:
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- 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.
