Job Title:Pharma Mfg Documentation SpecialistJob Description:Contribute to outstanding innovation + Make braver choices
Pharma Mfg Documentation Specialist
As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale while remaining agile and true to our 'people first' philosophy. Built on a 70-year commitment to science and research, Ferring is relentless in pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.
Support and maintain the FPG GMP Documentation Management and Archives. Provide support for GMP training program for Ferring Pharmaceutical Group (FPG), Parsippany, NJ site.
This position has overall responsibility for maintenance of FPG GMP documentation and archival system. This includes managing the FPG archives and record retention per procedure to ensure all GMP documents are filed and archived per Ferring's global and local procedures as well as maintaining FPG personnel signature logs.
This position will also support the FPG Training program, partnering with the Training Manager (Production) to develop and maintain GMP SOP curricula; system champion for Ferring's Learning Management System (LMS), providing training metrics and updates to management on the compliance of the program.
Managing the FPG archives and record retention per procedure to ensure all GMP documents are filed and archived per Ferring's global and local procedures.
Maintain FPG personnel signature logs/ files per procedure.
Support FPG Training Manager to monitor and track status of employee training, employee training files and training gaps in LMS.
Working closely with GMP departments develop, update and maintain all FPG GMP training curricula to ensure compliance with standard operating procedures); work practices (WP) and regulatory requirements.
Manage the collection of training events/evidence including the completion of required training curricula and the maintenance of Employee Training records, certificates, external training, etc.
Support Training Manager
Develop and maintain SOP training curricula for all FPG employees in LMS
Create training assessments for SOP training as required
Route training in LMS as required to ensure all GMP training is deployed as SOPs are created or updated
Develop and maintain metrics to optimize performance and productivity.
Track, trend and assemble documentation and training data for Quality Review Boards (QRB) and reports to management.
Any other duties as requested by QA Management
2-4 year degree in science, health sciences or other related field
3+ years in role within a GMP regulated environment
Experience with Documentation Management and Archives. Strong attention to detail.
Experience with various platform tools and databases such as those used for learning management (i.e. ComplianceWire, ISOTrain, etc.).
Strong computer skills. Experience with web-based applications and multimedia / video technologies a plus.
Experience and knowledge in document management, metrics, spreadsheets, etc.
Ability to work independently.
Working knowledge of cGMP, 21CFR 210 and 211, and 21CFR820 and other applicable regulations, standards and guidance.
Experienced user of Platform systems, Microsoft Word, Excel, Access, PowerPoint and Adobe Acrobat.
Familiarity with standard industry documentation, training, and metrics required.
Prospective new hires for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required on your start date unless an exemption has been approved by the Company as a medical or religious accommodation.
Join our team and you'll become part of a close-knit family - one in which you'll be listened
to and your contributions valued. Surrounded by like-minded people, you'll have the support to achieve more. So if you love to come up with new ways to make a positive difference and see them through, welcome to the team.
We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Location:Parsippany, New Jersey
We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled
Ferring Pharmaceuticals Inc.