MQA SPECIALIST II
Company: Fresenius Kabi AG
Location: Wilson
Posted on: May 19, 2023
Job Description:
Job Summary
POSITION SUMMARY
Performs routine audits of manufacturing areas to ensure product
quality and SOP/GMP compliance at the Wilson Manufacturing
Facility. Assists in troubleshooting manufacturing problems and
inspection defects. Provides plant support for collection of data
where needed, while assembling required metrics for review by
facility management. Updates controlled documents, including SOPs,
policies and batch records to maintain compliance in the production
areas.
Responsibilities
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
Global SOP requirements for MQA
- Drive a culture of continuous quality improvement by on the
shop-floor presence
- Act with competency, integrity and appropriately as Quality
Assurance personnel and assure that the processes required are
adhered to
- Authorized to stop production activities and contain materials
and/or products with immediate effect where Critical Deviations are
noted
- Escalate Isolated and Systemic issue to site management,
including proposed CAPAs
- Propose quality initiatives determined from periodic reviews,
inspectional observations, internal/external audits
- MQA shop-floor activities must cover the entire production and
support processes which, depending upon the plant's business
operations will include but not limited to:
- Weighing and Dispensing verification
- Bulk Solution Preparation
- Component Preparation cycle review confirmation for adherence
to SOP requirements
- Monitoring of In-Process Controls
- Oversight of Filling/Lyophilization filling activities
(including completion of Aseptic Gowning Qualification/adherence to
aseptic processing guidelines)
- Finishing Activities, including Integrity Testing Verification,
adherence of general inspection requirements/timelines, execution
of sampling plan
- Performance of Visual Inspection (AQL) and evaluate of defects
for particulate matter categorization
- Sterilization review
- Packaging oversight
- Warehousing/Storage requirement adherence
- Monitoring of Facilities and Utilities events for actions for
product safety/impact
- QA Key contact to shop floor employees, providing mentorship
and training on identified gaps and revisions
- On the floor QA Decision making & trouble shooting plant
support where necessary for troubleshooting of manufacturing,
facility and critical systems problems or special projects as
needed
- 5S, internal audit & inspection preparation activities
- Collects inspection, particulate matter, AQL and re-inspection
reject data on a monthly basis. Analyzes trend data
- Identify and initiate deviations in the production areas,
assure products are placed on SAP hold as required and initiate and
execute Action Plan requirements as needed to address investigation
or compliance related activities
- Review and approval of implementation of action (CAPAs & Change
Control Actions)
- Provide efficiency assessments (CAPAs & Change Control
Actions)
- Provide shop-floor documentation review as well as support for
batch record review for completion of checklist requirements,
including critical processing steps, in order to meet production
and release scheduling
- Shop-floor assessment of data governance principles
- Procedure review and approval, including periodic procedure
reviews for required revisions
- Verification of Audit Trails
- Support quality and compliance and continuous Improvement
projects
- Special oversight activities based on case by case demand to
include but not limited to:
- media fills
- repackaging
- reprocessing/reworking
- validation/investigation study activities
- other duties as assigned
REQUIREMENTS
- Associate degree or higher is required
- A minimum of three (3) to five (5) years' work experience
required, Pharmaceutical or Food Industry experience desirable
- A High School diploma with previous related field experience or
knowledge of a GMP
- A minimum of five (5) to ten (10) years' experience required,
Pharmaceutical, Medical Device or Food Industry experience
desirable
- Bachelor of Science degree or one (1) to three (3) years'
equivalent education/professional experience preferred
- Candidates must have knowledge of the competencies as described
below and complete the required training activities in the defined
timelines.
- Process, Product and container knowledge & expertise
- Knowledge & experience in Microbiology & aseptic technique
- Knowledge & expertise in regulatory requirements and industry /
company best practices approaches
- Competency in different computerized system (including the
software and audit trails)
- Knowledge of Word/Access and Excel applications is a plus
- Knowledge & expertise in data governance & integrity and
compliance requirements
- Understanding of the technology employed in production
activities
- Knowledge & expertise in application of Root Cause Analysis
tools & Methods
- Organizational abilities, troubleshooting capabilities, stress
resilience, personal integrity
- Relevant experience in shop floor functions
(production/manufacturing activities)
Additional Information
We offer an excellent salary and benefits package including
medical, dental and vision coverage, as well as life insurance,
disability, 401K with company match, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment
without regard to race, color, religion, sex, national origin,
citizenship, immigration status, disabilities, or protected veteran
status.
Keywords: Fresenius Kabi AG, Wilson , MQA SPECIALIST II, Other , Wilson, North Carolina
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