Sr Quality Systems Specialist

Manages activities associated with the recall program for all US pharmaceuticals manufacturing and contract manufacturing facilities

o Manages recall initiation activities, including preparation of required documentation for submission to FDA, review of recall documentation for accuracy, preparation of customer recall packets

o Manages customer responses and interfaces with customers via phone, email and fax with a professional demeanor at all times . Collaborates with Customer Service, Credit, and Distribution Center personnel to resolve customer issues related to recalls

o Manages recall tracking activities, including recall responses, monthly tracking and recall reconciliation

o Serves as a backup to the Manager, Quality Systems in recall initiation, preparation of monthly recall status reports, recall termination, and communication with FDA

o Manages the Fresenius Kabi USA Procedural Compliance Program to ensure adherence with regulatory requirements, ISO 9001, and Fresenius Kabi Global Quality Management policies and procedures

o initiates new revised global document gap assessment records for all US sites and ensures on time completion- Performs gap assessments of Regional documents against global documents and/or regulatory guidelines

o Updates and authors procedures as required

o Performs periodic reviews and updates of Regional documents

. Performs internal self-assessments for Regional QA to ensure procedural compliance

. Launches and drives compliance initiatives based on new regulations, guidance documents and industry standards

o Manages customer requests for questionnaires, certificates, other information requests

. Supports and participates in internal, external, customer and regulatory inspections as needed

. Maintains files for Fresenius Kabi USA FARs, regulatory contact logs and regulatory inspections

o Additional tasks as needed

All employees are responsible for ensuring the compliance to company documents, programs and activities

related to the Health, Safety, Environment, Energy and Quality Management Systems. as per your roles and

responsibilities

Requirements

• Bachelor's degree in the sciences with a minimum of 5 years of progressive challenging Quality Assurance experience in pharmaceutical or related industry
• Working knowledge of FDA and ISO 9001 guidelines
• Strong computer skills with proficiency in Microsoft applications
• Possesses strong interpersonal skills, verbal/written communication skills, and problem resolution skills
• Demonstrated ability to handle multiple projects simultaneously
• Must be organized, detailed and have the ability to handle multiple tasks at once and redirect focus based on business needs and priorities.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness 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.