MQA SPECIALIST II
Company: Fresenius Kabi AG
Posted on: September 18, 2022
Performs routine audits and inspections of manufacturing areas to
ensure product quality, SOP and GMP compliance. 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 a state of Quality Control in the production areas.
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
- Performs audits of all operating areas and participates in
scheduling of the internal audit program. Issues results to area
supervision. Ensures issues are reviewed and corrective action
- Performs AQL checks on product when necessary and maintains
Inspector and AQL qualification status.
- Addresses daily quality concerns and questions related to
operations and environmental concerns. Implements and follows up on
- Provides additional support for batch record review and
critical processing steps in order to meet production and release
- Becomes gown qualified and maintains status for entry into
Aseptic processing area in order to investigate potential
deviations and compliance risks.
- Assures standard operating procedures (SOPs) and batch records
define the steps necessary to complete tasks. Writes, reviews, and
updates documents as needed.
- Identifies and initiates deviations in the production areas,
assures products are placed on SAP hold as required and initiates
and executes Action Plan requirements as needed to address
investigation or compliance related activities.
- Collects inspection, particulate matter, AQL and re-inspection
reject data when needed and analyzes trend data.
- Assists in analysis of inspection rejects; assists in
investigation of causes and implementation of corrective action
using TrackWise or other approved investigational tools.
- Provides plant support where necessary for troubleshooting of
manufacturing problems or special projects as needed.
- Attends plant meetings, communicates quality notes and provides
necessary support with ECRs, EODs, etc.
- Calculates, revises or reviews SPC limits for filling
operations. Performs analysis for fill operations utilizing
Statistical Process Control.
- Supports validation projects with required data collection. May
function as a Study Director for qualifications and/or
- Issues/aprovs ECR using Trackwise.
- Performs Mean Kinetic Temperature (MKT) calculations.
- Performs additional duties and responsibilities as
- May become a qualified trainer.
- Bachelor of Science degree or three (3) to five (5) years
equivalent education/professional experience required.
- Pharmaceutical industry experience desirable.
- Knowledge of a production facility and/or inspection processes
are a must.
- Oral and written communication skills required between
department, as well as levels of management.
- Computer experience required. Must be proficient in Microsoft
Word and Excel functions
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
Keywords: Fresenius Kabi AG, Wilson , MQA SPECIALIST II, Other , Wilson, North Carolina
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