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Quality Assurance GMP Inspector

Company: OraSure Technologies
Location: Bethlehem
Posted on: February 19, 2021

Job Description:

To participate and support activities in the Quality Assurance/ Regulatory Compliance Department to ensure that all goods manufactured and services provided by the Company meet the quality requirements of the Company, regulatory and notified bodies.

ESSENTIAL DUTIES AND RESPONSIBILITIES1. In the role of GMP Inspector- perform in-person reviews of:-- GMP practices across the Bethlehem facilities. Tasks will include ensuring product that is tagged as "rejected", "Quarantine", "Scrapped" is appropriately labeled and segregated according to established procedures. Ensures approved material is appropriately labeled.-- manufacturing areas, laboratories and warehouse. Tasks will include ensuring that material is appropriately stored in designated locations, that material is appropriately physically and electronically segregated and wrapped if required.-- manufacturing and inspection areas as it relates to batch records. This includes spot checks of batch records, equipment logs and other manufacturing related documents to ensure that they are being completed per procedural requirements. Will perform, as directed by procedure reviews of batch changes and line clearances.2. In the role of Label Control Coordinator- facilitate the control of product labeling utilized in manufacturing processes across all Bethlehem facilities. Control of product labeling includes storing, handling, generating (printing), issuing and reconciling all materials defined as product labeling when required.3. Will escalate in a timely manner issues that do not meet procedural or good manufacturing practices (GMP) to appropriate management for immediate action. Will raise NCR's if nonconforming situations are identified.4. Initiate improvements to the Quality Management System, ensuring compliance to all relevant Quality Standards and Regulatory requirements.5. Write and maintain procedures/processes relating to the Quality Management System. Prepare and present quality reports, data and Key Performance Indicators to management for review.6. Assist in ensuring understanding and compliance with the requirements of cGMP as applied to the company's products and processes. As needed, assist in providing training and support to other departments.7. Advise and assist with resolution of any GMP issues identified.8. Participate in and support internal audit program, and/or other audits as needed. Ensure timely, accurate completion of audits.9. Support other departmental activities as requested by department management or designate.

QUALIFICATIONS1. Demonstrated knowledge of document control systems.2. Experience with internal audit processes desired.3. Demonstrated knowledge of cGMPs, FDA regulations, and SOP's.4. Demonstrated advanced computer skills - Microsoft Office preferred.5. Excellent verbal, written and interpersonal skills, including the ability to conduct verbal presentations appropriate to the level of the audience.6. Demonstrated success working in a team environment.7. Ability to travel by car and/or plane between OraSure sites.

EDUCATION AND/OR EXPERIENCE 1. Bachelors/Undergraduate Degree in quality, science, or engineering discipline (chemistry, biology, or medical technology preferred).2. Minimum of two (2) years progressively responsible experience in a drug manufacturing, medical device, or biologics industry in Quality Assurance or Quality Engineering position.3. Certification as auditor or Quality Engineer (ie ASQ) preferred.
OraSure and its subsidiaries is committed to ensuring equal employment opportunities for all. All employment decisions, policies and practices are in accordance with applicable federal, state and local anti-discrimination laws.

Keywords: OraSure Technologies, Bethlehem , Quality Assurance GMP Inspector, Other , Bethlehem, Pennsylvania

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