Associate, Quality Assurance
Location: Parsippany, New Jersey
Description: Ferring Pharmaceuticals, Inc. is at present looking to employ Associate, Quality Assurance right now, this occupation will be ordered in New Jersey. Further informations about this occupation opportunity please read the description below. Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with over 5,700 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women’s health (obstetrics/gynecology) and orthopaedics. Ferring’s US operations employ approximately 800 people.
People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.
Summary:
The Associate, Quality Assurance will perform activities related to QA oversight of manufacturing, packaging/labeling, inspection, QC laboratory, and plant maintenance / engineering to maintain acceptable GMP regulatory compliance and quality performance.
Review and approval of executed batch records. Authors and reviews FPG local SOPs to ensure compliance with cGM Ps, Good Documentation Practices, local requirements, and corporate standards.
Primary responsibility for managing the product quality complaint process utilizing QA-Track. Leads and/or participates in the resolution and review of complaint investigations, and corrective/preventive actions (CAPAs). Performs tracking, trending, and reporting of complaint metrics to ensure a state of control.
Leads and/or performs deviation investigations for Quality and Compliance or Product Supply issues, and partners cross functionally to bring issues to timely closure; including deviations, CAPA, and change control.
Responsibilities:
Review and approval of executed batch records: media fills, compounding/filling/capping/terminal sterilization, visual inspection, labeling and packaging. Meet department metric for schedule adherence.
Initiates and/or performs deviation investigations for quality/compliance related matters and partners with Qua lity and Product Supply to bring issues to timely closure.
Executes the Product Quality Complaint investigation process by:
Perform and/or ensure proper investigation and documentation of drug product complaints associated manufacturing investigations.
Ensure completion of product quality complaint, sample evaluation.
Monitor trends and highlight risk factors for product quality complaints including response times, outcomes, and actions arising from complaints.
Perform routine monitoring of manufacturing, packaging, QC, and maintenance/engineering areas to ensure compliance with all approved SOPs
Contributes to the Annual Product Review process, including scheduling, collection of data, and report preparation.
Support the GMP training program.
Authors and reviews local SOPs to ensure compliance with GDPs, local requirements, and corporate standards.
Monitor and track status of the SOP/document management process.
Performs other duties as assigned by Quality management
Requirements:
Bachelor of Science degree in Natural Sciences or Engineering from an accredited college/university is required.
A minimum of seven (7) years of GMP quality assurance experience in pharmaceutical or biopharmaceutical industry is required.
Understanding of the requirements for quality documents in a FDA regulated industry is required.
Direct experience with document management, SOP development, and training is required.
Experience with providing direct oversight and support to commercial manufacturing operations is highly preferred.
Experience performing deviation investigations including CAPA planning and management is highly preferred.
MS Office applications, LIMS, Trackwise, and Oracle are preferred.
Excellent problem-solver with the ability to work independently.
Demonstrated ability to interpret cGMP, 21CFR 210 and 211, and other applicable regulations, standards and guida nce.
Knowledge of working in quality systems within the pharmaceutical / biopharmaceutical industries.
Experience with, or direct knowledge of quality system elements (e.g. product disposition, product quality complaints, document management, change control, deviation investigation, CAPA, management review / metrics reporting, data integrity, qualification/validation Annual Product Review).
Strong verbal and written communication with ability to communicate complex ideas and concepts
Strong attention to detail, i.e. reviewing batch record and documentation for adherence to SOP format requirements; accurate data entry of documentation into a database
Ability to effectively negotiate and influence key partners and suppliers to meet requirements and commitments
Works independently with minimal supervision
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We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled
We maintain a d rug-free workplace and perform pre-employment substance abuse testing.
If you need assistance during the application process due to a disability, please email careers@ferring.com .
Location:
Parsippany
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If you were eligible to this occupation, please send us your resume, with salary requirements and a resume to Ferring Pharmaceuticals, Inc..
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This occupation will be opened on: Fri, 23 Feb 2018 19:01:36 GMT