Quality Supplier Specialist
Company: Apex Systems
Posted on: June 13, 2021
Apex Systems has an immediate need for a Quality Supplier
Specialist in the Harmans, MD area.
Responsibilities of Quality Supplier Specialist:
- Supports management of suppliers through various systems
(supplier qualification audits, change notification, periodic
- Helps identify compliance risks and works cross-functionally to
identify and implement resolutions. Escalates significant
compliance and/or business risks to management.
- Maintains, analyzes and develops plans for improving quality
metrics for Supplier Management and Internal Auditing
- Supports periodic Internal Audits of all functional
- Performs follow-ups to ensure action items from responses to
internal and external audit observations are complete.
- Assists with internal auditing schedules to assure adherence to
internal operating procedures and GMP regulations.
- Supports monitoring of internal audit commitments, ensuring
- Stays current in GXP expectations, including FDA, EU and other
relevant foreign regulatory bodies, guidance documents (i.e.: ICH,
PTC, ISPE, etc.), and best industry practices.
- Supports regulatory inspections as necessary.
- Build and maintain successful cross-functional relationships
with internal customers such as Manufacturing, Analytical, Quality
Control, and Facilities Engineering.
- Ability and willingness to work in a fast-paced
- Excels at multi-tasking and responding to Compliance Management
requests to shift focus between Internal Audit and Supplier
Required Education/Experience of Quality Supplier
- Bachelor's degree in biological science or technical
- Minimum 2+ years' experience in GMP pharmaceutical, biologics
and/or vaccine manufacturing.
- Knowledge and expertise in principles and practice of current
Good Manufacturing Practices (GMPs) from development through
- Knowledgeable of FDA and EU regulations regarding the
manufacture of biologicals including regulatory inspection
- Knowledge and experience in auditing Drug Substance
manufacturing, Formulation/Fill finish manufacturing, and Material
- Excellent multi-tasking, analytical, organizational and
- Ability to troubleshoot, identify root cause and systematically
- Proficient in Window based software to include Excel and Word.
Ability to adapt to changing software programs.
- Ability to communicate clearly and effectively with all levels
of the organization.
- Ability to use MS TEAMS efficiently to communicate
- Ability to work remotely and on-site
Apex Systems is an equal opportunity employer. We do not
discriminate or allow discrimination on the basis of race, color,
religion, creed, sex (including pregnancy, childbirth,
breastfeeding, or related medical conditions), age, sexual
orientation, gender identity, national origin, ancestry,
citizenship, genetic information, registered domestic partner
status, marital status, disability, status as a crime victim,
protected veteran status, political affiliation, union membership,
or any other characteristic protected by law. Apex will consider
qualified applicants with criminal histories in a manner consistent
with the requirements of applicable law. If you have visited our
website in search of information on employment opportunities or to
apply for a position, and you require an accommodation in using our
website for a search or application, please contact our Employee
Services Department at firstname.lastname@example.org or
Keywords: Apex Systems, Baltimore , Quality Supplier Specialist, Other , Harmans, Maryland
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