QA Specialist - 1st Shift

Position Summary :

The Quality Assurance Specialist works within the Quality Department to assist in compliance activities of the quality system and participate in continuous improvement activities.

The primary function of the QA Specialist is to provide review and release of product records to ensure compliance to company procedure and applicable federal, state, local, and accreditation standards.

The position responsibilities may include the following, although other duties and responsibilities may be assigned as necessary :

Essential Functions :

• Performs data entry review and release ensuring entry of finished goods coincides with the Distribution software
• Performs secondary review of Donor Processing Records for terminally sterilized and aseptic lines
• Coordinates with the QA Systems Team Lead or Management to prioritize product release
• Performs release functions to finished goods
• Reviews test reports as part of release criteria
• Reviews technical and performance specifications
• Reviews irradiation shipment documents for acceptability
• Verifies domestic or international requirements for product release
• Investigates and tracks status of records pending release
• Assists in onboarding new private label clients by verifying label requirements prior to use
• Assists Distribution department with the review and release of re-designated products as requested
• Performs Quality review of assigned records or logs and verifies procedure requirements were met for approval and closure of the records
• Maintains error spreadsheets and creates graphs / trending reports as needed
• Assists with performing the monthly inventory of QA product
• Reports non-conformances and discrepancies.
• Participates in continuous improvement initiatives and implementations.
• Other duties and responsibilities as assigned.
• Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.

Ensure Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role.

Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties of Globus.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications :

• Bachelor’s degree preferred.
• Experience performing file reviews and / or audits.
• QA or QC experience within the biotech / tissue banking industry preferred.
• Knowledge of GMP regulations preferred
• Must be knowledgeable with Microsoft Word and Excel programs.
• Strong typing skills, analytical skills, and problem solving techniques.
• Excellent communication and writing skills.

Our Values :

Our Life Moves Us philosophy is built on four values : Passionate About Innovation, Customer Focused, Teamwork, and Driven.

Passionate about Innovation : Improving patient care by delivering advanced technology to our customers is at the core of what we do.

We are passionate in our role in improving the lives of patients by continuously developing better solutions

• Customer Focused : We listen to our customers’ needs and respond with a sense of urgency
• Teamwork : Working together, anything is possible. We value every person on our team and treat each other with respect.

We are accountable to one another and support each other. Together, we make each other stronger

Driven : We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.

Physical Demands :

The physical demands listed here are representative of those that must be met by and employee to successfully perform the essential functions of this job.

• Required to sit; climb or balance; and stoop, kneel, crouch or crawl
• Required to regularly lift and / or move up to 10 pounds, and occasionally lift and / or move up to 25 pounds

Required to possess specific visons abilities, including : close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus.

Equal Employment Opportunity :

Globus Medical is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, age, disability, marital status, pregnancy, national origin or citizenship.

We are committed to a diverse workforce. We value all employees’ talents and support an environment that is inclusive and respectful.

Other Duties :

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.

Duties, responsibilities and activities may change at any time with or without notice.

JOB CODE : 1003392