Quality Control Reviewer, 1st Shift

Regulatory Jobs; Lower Providence Township (PA); Presencial; USD 52.000 - 76.000; Jornada completa

Descripción de la vacante

Globus Medical is seeking a Quality Assurance Reviewer to join the QA Operations team to review device and product records and ensure compliance with release criteria. The reviewer will also ensure documents are scanned and logged into the electronic record system.

Responsibilities include batch record review, COA/test report review, and maintaining accurate records while adhering to SOPs and regulatory requirements.

Formación

• Minimum of one year experience with document review.
• Familiarity with GMP and SOPs to ISO standards is a plus.
• Strong organizational and time-management skills.

Responsabilidades

• Performs batch record review and release functions.
• Reviews certificates of compliance or test reports.
• Reviews receiving inspection documentation.
• Reports non-conformances and discrepancies.
• Generates Excel spreadsheets to record review activities.
• Ensures that finished batch records are scanned and logged into the electronic record system.

Conocimientos

MS Excel

Document review

Attention to detail

Educación

High School Diploma

Herramientas

MS Office

Descripción del empleo

At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering with researchers and educators to transform clinical insights into tangible solutions. Our solutions improve the techniques and outcomes of surgery so patients can resume their lives as quickly as possible.

Position Summary:

The Quality Assurance Reviewer will work within the QA Operations department to provide reviews of device and product records to ensure compliance with applicable release criteria. The QA Reviewer will also ensure that completed documents are properly scanned, filed, and logged into Globus’s electronic record system.

Essential Functions:

• Performs batch record review and release functions
• Reviews certificates of compliance or test reports
• Reviews receiving inspection documentation
• Reports non-conformances and discrepancies
• Generates Excel spreadsheets to record review activities
• Ensures that completed batch records and other applicable Quality documents are scanned after completion
• Achieves targeted goals as set by the production schedule
• Follows proper safety precautions and all SOPs
• Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
• Ensures 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 upholds the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties

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

Qualifications:

• Minimum of one (1) year experience with document review; familiarity with GMP and SOP’s to ISO standards is a plus
• High School Diploma or equivalent
• Self-starter with the ability to show initiative in assignments; willingness to continually strive to increase knowledge and skills
• Strong organizational, problem-solving, and follow-up skills; Ability to work in a fast-paced environment while multi-tasking and maintaining attention to detail
• Proficient in MS Office, especially MS Excel

Physical Demands:

The physical demands listed here are representative of those that must be met by an 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

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.

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.