MQA SPECIALIST II - OVERNIGHT SHIFT

Company: Fresenius Kabi
Location: Melrose Park
Posted on: November 26, 2022

Job Description:

Join a global healthcare leader where you work with a clear purpose and career growth opportunities.
*Health Benefits begin day 1 of employment: *
Health Insurance
Dental Insurance
Vision Insurance
Prescription Coverage
Flexible Spending Accounts
*We also offer the following benefits: *
3 Weeks Paid Vacation, Holiday pay and paid Sick time
401(k) with a company contribution that is 100% vested
Tuition Reimbursement
Employee Assistance Program
Disability Insurance
Life Insurance
Dependent Spouse and Child Life Insurance
Auto and home insurance programs
Legal Insurance
Conduct routine audits of manufacturing areas to ensure product quality and SOP/GMP compliance. Assist in troubleshooting manufacturing problems and inspection defects. Provides plant support for the 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.
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
* 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
Key skills for success:

* Associate degree or higher is required, plus 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, plus 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.

Job Type: Full-time

Pay: $70,000.00 - $85,000.00 per year

Schedule:
* 12 hour shift
* Night shift

Work Location: One location%2179614%

Keywords: Fresenius Kabi, Chicago , MQA SPECIALIST II - OVERNIGHT SHIFT, Other , Melrose Park, Illinois