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Associate, Quality Assurance

4 months ago

Parsippany, United States Ferring Pharmaceuticals Inc. Full time
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 Associate, Quality Assurance you will be responsible for creating and maintaining current specifications, addressing change controls for specification updates, working with quality metrics, SOPs, deviations, CAPA to assist with ensuring the site is in compliance with SOPs and regulatory requirements. Will be a back-up for other responsibilities to ensure proper staffing to meet departmental timelines.

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:

  • Creation and revision of specifications for current materials/products and new materials/products supporting tech transfer activities and artwork revisions.
  • Create, manage, and/or implement change controls for various activities.
  • Creation or review of quality metrics for monthly Quality Review Board meetings. Ensure metrics are met for items personally responsible for.
  • Knowledge of deviation and CAPA system - able to perform investigation and root cause analysis.
  • Participate in internal audits and regulatory inspections as required.
  • Creation and revision of SOPs utilizing an electronic system.
  • Review of QC test data for incoming bulk, raw materials and components, and release testing for products manufactured at the site. Knowledge of LIMS and Oracle systems.
  • Batch Record Review for media fills, compounding/filling/capping, visual inspection, labeling and packaging activities.
Requirements:
  • Bachelor degree in Life Sciences
  • Minimum 5 years of Quality Assurance experience in the pharmaceutical industry
  • Knowledge of sterile operations preferred.
  • Knowledge of cGMPs and GLPs
  • Demonstrated effective communication and interpersonal skills across multiple departments.
  • Strong organizational skills


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 $ 61,750 to $143,000, 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

Location:
Parsippany, New Jersey