The QA Specialist will report to the Quality Assurance Manager within the Quality Department of the Angelini Albany ThermaCare production facility. This position
Supports the development, implementation and monitoring of Quality and Regulatory Compliance strategies for medical devices within the Infection Prevention function and at the manufacturing site in Albany.
Supports inspection readiness of the site at all times and compliance with all applicable regulations within the scope of the manufacturing site's activities.
Supports quality systems improvement plans when needed.
Role
Perform Management of Quality aspects (quality documentation, Quality Assurance Agreements, Audits, Complaints, CAPA) including relationships with relevant local Contract Manufacturer Organizations, manufacturers and warehouses, and third party logistics.
Act as Audit Team member including internal and regulatory audits such as FDA inspection as Specification Developer and EPA Annual Audit (preparation, hosting, follow-up).
Support roll-out and maintenance of Global Quality Management System tools.
Assess Local SOPs against Global procedures and ensure applicable Training.
Manage Complaint Register; Recalls and Mock recalls.
Draft and update quality documents and procedures (SOPs).
Perform SAP transactions as necessary.
Support other quality-related activities as needed.
Professional Profile
2+ years of experience in a GMP regulated environment, required.
Knowledge of FDA 21CFR Part 820 and EPA regulations for antimicrobial pesticides (sanitizers and disinfectants), required.
B. Sc. degree in life science, engineering or other related degree, preferred.
Knowledge of medical devices regulations and ISO Standards i.e., EU MDR and ISO13485:2016, preferred.
The ability to lead efforts aimed at the identification of problematic situations, reporting issues, and the development of resolutions and decision making is required.
SAP and TrackWise knowledge a plus
Professional communication skills, written and oral, with excellent computer skills including Word, Power Point and Excel, at a minimum.
Ability to work effectively in a team environment and communicate with team members and colleagues at all levels of the organization, both in person and remotely.
Strength in prioritizing and handling several projects concurrently and meeting strict deadlines.
Open minded and flexible, able to understand other cultures, professional maturity.
Potential to handle larger responsibilities.
About Us: Angelini is a medium size private international group, a leader in health and wellness in the field of pharmaceutical and consumer products. Born in Italy in the early twentieth century, the Angelini group has offices in 17 countries and worldwide distribution of products. Angelini Pharma Inc. is the US business unit, headquartered in Atlanta, GA. In 2020 Angelini Pharma Inc. acquired the ThermaCare production facility in Albany, GA.
Angelini Pharma is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity and/or expression, sexual orientation, national origin, genetics, disability, age or veteran status.