Specialist, Quality Systems Document Control

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 Specialist, Quality Systems Document Control, you will responsible to maintain the GxP document management system for Ferring US, Parsippany, NJ site.

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:

• Support the maintenance and administration of various local GMP documents (i.e. manufacturing, validation, SOPs, Work Instructions, specifications, methods, APRs, Logbooks, controlled forms, other protocols/reports, signature logs, completed training forms) in the Ferring's document management system. This includes monitoring the completion of periodic review process of local GxP documents.

• Prepare and update quality SOPs.

• Responsible for document control, including document identification (if applicable), tracking, verifying, distributing, and archiving of GxP documentation to support Ferring US, as applicable. Ensure a controlled distribution.

• Issuance, tracking and reconciliation of GMP documents such as batch records, logbooks, forms, worksheets, etc.

• Generate monthly reports and present data to Ferring US QA Leadership Team.

• Assist in other quality and administrative functions, as necessary.

Requirements:

• Bachelor's degree in a natural sciences, pharmacy, or engineering from an accredited college or university preferred

• A minimum of three (3) years of GMP quality assurance experience in biotechnology, pharmaceutical, or medical device industry

• Prior experience in review of manufacturing records, quality control data, and quality system records.

• Working knowledge following Standard Operating Procedure (SOP), document management/control system processes

• Microsoft Office skills WORD,EXCEL, POWER POINT

• Resourceful in problem-solving with the ability to work independently

• Working knowledge of document control/management and training systems within the pharmaceutical/biopharmaceutical or medical device industries.

• Working knowledge of cGMP, 21CFR 210 and 211, 11 and 820 and other applicable regulations, standards and guidance.

• Familiarity with standard industry documentation, training, and investigations practices is required.

• Strong verbal and written communication

• Strong attention to detail, i.e. reviewing documentation for adherence to SOP format requirements; accurate data entry of documentation into a database

• Attention to detail and consistency across documentation

• Ability to effectively negotiate and influence key partners to meet requirements and commitments

• Drive for Results

Role will be in Parsippany, NJ.

Ferring + you

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. 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