The Quality Assurance Compliance Specialist II performs compliance activities in support of production, engineering and Research & Development ensuring all activities are performed according to internal Quality System requirements, cGMP, FDA, EU and ISO 13485 standards. Areas of responsibilities include review of documents such as batch records, charts and logs review 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 Compliance Specialist II also performs audits as assigned 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.
- Review batch records and certificates of analysis for accuracy and completion prior to final release of product
- Coordinate product releases with distributors and customers
- Reconcile batch records as needed
- Review and approve incoming materials for release
- Review and approve supplemental logs, charts, preventive maintenance work orders and other documents in support of cGMP operations
- Provide quality assurance support of investigations including: nonconformance, CAPA, root cause analysis, out of specifications, environmental excursion and calibration.
- Provide quality input for planned deviations and change controls
- Maintain device history files, update or review device master records as needed
- Perform quarterly walkthrough audits of manufacturing and packaging, complete audit activities as assigned
- Assist in training quality assurance personnel and other cross functional personnel as needed
- Assist in the maintenance and implementation of the Quality System
- Revise and review procedures for improvement based on process knowledge
- Participate in project teams and perform other related duties as assigned
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.
- Bachelor’s Degree required, preferably in the life sciences or relevant experience.
- 2 – 4 years’ experience in the medical device and/or pharmaceutical industries working in Quality Assurance/Quality Compliance role
- Knowledge of GMP, FDA, EU, ISO requirements, specifically ISO 13485 Medical Devices
- Experience reviewing batch records and releasing products
- Requires computer competence, including experience with database and Microsoft Office
- Excellent written and verbal communication skills
Desired Experience, Knowledge, and Skills:
- High attention to detail and ability to follow processes
- Experience auditing in a GMP/ISO environment
- Good presentation and organization skills
We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.