MQA Specialist - 2nd Shift

Responsibilities

Position is responsible for quality oversight and assistance to production processes, supporting departments and laboratories.

Position recommends corrective action in response to deviations noted. Assures compliance to Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMPs).

Maintains the finished product reserve appropriate sampling and FDA retention sample storage areas.

Drive a culture of continuous quality improvement by being present on the shop-floor.

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 issues to site management, including proposed Corrective Actions and Preventive Actions (CAPAs).

QA key contact to shop floor employees.

On the floor QA contact to escalate issues and provide real-time documentation requirements/troubleshooting analysis.

Support in investigations & root-cause analyses (incidents & investigations).

Shop-floor documentation review of MBRs and logbooks for GMP and procedural compliance.

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, reworking, validation/investigation study activities, other duties as assigned.

Requirements

Minimum of High School Diploma with one (1) to three (3) years of work experience required.

Associate degree or High School diploma with previous related field experience or knowledge of a GMP – regulated industry preferred.

Candidates must have knowledge of the competencies as described below and complete the required training activities in the defined timelines:

• Knowledge & expertise in regulatory requirements and industry / company best practices approaches
• Competency in different computerized systems (including software)
• Knowledge of Word/Access and Excel applications is a plus
• Aptitude for understanding of the technology employed in production activities
• Organizational abilities, troubleshooting capabilities, stress resilience, personal integrity

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 contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at-will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

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.