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 the Quality Control, Compliance Specialist, you will act as the primary source of contact for the second and third shift teams; oversee day-to-day service of production equipment.

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:

• Serves as Lead investigator and writer for Lab related issues.
• Conducts formal investigations, including the review of raw data, and other documentation regarding product release and stability.
• Ensures that lab investigations are completed within the required time schedule per quality systems and procedures
• Communicates OOS findings immediately to Site Leadership and acts with a sense of urgency to investigate
• Assures all exception documentation adequately address root cause, corrective & preventive actions and product impact.
• Ensure root cause, corrective action, preventative action, and product impact are thoroughly addressed in investigations.
• Develops, implements, manages and tracks effectiveness of corrective action plans for exceptions
• Participates in Quality Review Board representing the QC Laboratory and communicating status, root cause, and CAPAs
• Coordinates and lead USP/EP/ICH Committee to assess and trigger change implementation to remain in compliance.
• Assists in the review, approval, and issuance of laboratory documents including SOP’s, testing protocols, new testing methodologies, etc.
• Assist with GMP Compliance program in the QC Laboratory, including management of training records, internal and self-audits, compliance walk thrus, SOPs and Methods, deviation reduction initiatives, etc

Requirements:

• Bachelor’s Degree in a scientific/technical discipline
• A minimum of 3 years of industry experience with a tleast one in QC Laboratory settings
• Expertise with performing laboratory investigations, change controls, and associated CAPA under limited guidance
• Working knowledge in Labware LIMS configuration of new analyses and product specifications.
• Working knowledge of analytical method development, transfer, and validation methodologies and relevant guidance’s
• Knowledge of USP/EP/cGMP and ICH guidelines; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWise); Microsoft Office; Lean Six Sigma concepts; Lean Labs; project management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.

Place 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 frontloaded yearly of 40 hours, or higher if state or local law requires; vacation time for full time employees to accrue between 112.5 and 150 hours yearly in the first four (4) years of employment, and additional accruals starting in the fifth (5th) year of employment; and 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. For roles that are not field-based, Ferring has a policy that allows employees to work up to two days from home and three at a Ferring site, weekly.

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 gender, race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, 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.

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