Quality Assurance GMP Inspector
Company: OraSure Technologies
Location: Bethlehem
Posted on: February 19, 2021
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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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