As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and 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 plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and... more details
Job Description:
As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and 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 plus commitment to science and research, Ferring is relentless in its 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.
As Senior Specialist, QA Document Control Management, you will be responsible for managing electronic document workflows, archiving documents, ensuring compliance with Good Document Practices (GDP), and providing training to personnel at all levels. This role requires strong computer enterprise experience, particularly with MS Office and Electronic Document Management Systems (eDMS).
With Ferring, you will be joining a recognized leader, identified as one of “The World’s Most Innovative Companies” by Fast Company, and honored by Fortune with inclusion on its “Change the World List,” for addressing society’s unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.
Responsibilities:
eDMS Workflow Management: Handle the electronic document management process, from workflow initiation to review and approval collaboration, document approval, effectiveness, and coordinate with the Training team to release documents within the learning management system.
Document Formatting and Wrapper Management: Manage internal and external executed service documents (SOPs, validation, analytical testing, etc.) within eDMS workflows, ensuring correct formatting and applying document wrappers when applicable.
Logbook Issuance and Retrieval: Issue and retrieve logbooks from Technical Operations as needed.
Document Verification: Verify and check documents before archiving to assure Good Document Practices (GDP) and data integrity ALCOA+ principles.
Document Archiving: Archive documents throughout their lifecycle, including paper and electronically generated documents into eDMS (i.e., Veeva, REAL QUMAS).
Traceability Assurance: Manage the post-review process of executed documents, ensuring full traceability and compliance with Good Document Practices (GDP) and data integrity ALCOA+ principles.
GxP Records Digitization: Digitize through scanning executed Technical Operation (i.e., Master Batch Records), and other GxP Records to maintain a certified record.
Audit and Inspection Support: Provide support during audits and inspections, including document retrieval and assistance as required.
Training and User Support: Create user-friendly training materials and provide training to personnel at all levels for self-directed execution of eDMS workflows (Author, Owner, Reviewer, Approver, etc.).
Periodic Document Review: Manage the periodic review of Ferring US Documents, including communication at 90, 60, and 30 days in advance, follow-up, tracking, and escalation when necessary.
Quality Compliance Metrics: Generate, publish, and communicate Document Control Management (DCM) Quality Compliance Dashboards and Metrics to drive compliance and continuous improvement.
Continuous Process and System Improvement: Seek opportunities for process and system improvements, create/revise procedures, share insights with management, and provide a balanced analysis of pros and cons for consideration.
Requirements:
BA/BS degree in a natural or health science field.
Significant relevant experience in the biopharmaceutical industry.
Expert computer skills, including high proficiency in MS Office applications.
At least 4 years of experience with Electronic Document Management Systems (eDMS) such as Veeva, Documentum, QUMAS, etc.
Knowledge of Good Document Practices (GDP) and data integrity ALCOA+ principles.
Experience working with manufacturing/packaging batch records and other GMP technical documents is preferred.
Strong attention to detail and organizational skills.
Excellent communication and interpersonal skills.
Ability to work collaboratively in a team environment.
Proven ability to train and support personnel at all levels.
Passion for continuous improvement and quality compliance.
Role will be in Parsippany, NJ.
At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry’s most impressive people, these are just some of the ways we live our "People First" philosophy.
Our Compensation and Benefits
At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $46,265 to $110,500, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. [If applicable] If hired to work 2nd in this role, the pay differential will be 10%. [If applicable] If hired to work 3rd shift in this role, the pay differential will be 20%. [For non-sales employees] Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.
Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 12 to 13 paid holidays per year. We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package here.
Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.
Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.
We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.
Location:
Parsippany, New Jersey