Associate, Production Compliance
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 Production Compliance, you will be a member of the Production/Packaging group responsible for activities associated with the manufacture of safe, effective, and sterile pharmaceuticals in accordance with industry regulations and company SOPs, policies and cGMPs.
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.
Responsible for investigation of production and packaging deviations.
Responsible for deviation root cause determination and initiation of associated CAPAs.
Management and implementation of department CAPAs.
Initiation of process and documentation Change Applications and Change Controls.
Responsible for review of qualification and validation documents associated with their area of responsibility.
Revision and update of SOPs.
SOP and Batch Record revisions due to new equipment, processes and/or new drug products.
Participate in internal and external quality audits, as needed.
Assist in training production personnel on compliance-related procedures and standards.
Collaborate with cross-functional teams to identify opportunities for process and compliance improvement.
Generate and communicate compliance reports and metrics to management.
Attends all training programs as required by Company SOPs, procedures, and policies.
Perform any other tasks/duties as assigned by management.
Bachelors in Pharmaceutical Science, Chemistry, Biology, Engineering, required.
Minimum 5 years’ experience in the pharmaceutical manufacturing industry with GMP/FDA regulations required.
Minimum 3 years’ experience in aseptic/sterile pharmaceutical manufacturing industry is required.
Experience gowning into grade B and C environments.
Experience writing, reviewing, and executing standard operating procedures and work instructions.
Experience writing, reviewing, and executing operation batch records.
Experience writing, reviewing deviations.
Excellent independent time management skills.
Proven ability to plan and track deliverables and timelines.
Proficient Microsoft Office applications.
Ability to work on and coordinate multiple projects in an orderly and efficient manner, consistently meeting established deadlines.
Ability to work cross-functionally to meet company objectives.
Strong knowledge of pharmaceutical manufacturing processes.
Working knowledge of Good Manufacturing Practices (US)
Strong oral and written communication skills
Ability to quickly understand detailed and complex processes.
Excellent organizational and administrative skills.
Ability to self-manage and prioritize workload.
Stand or sit for extended periods, especially during production process monitoring and audits.
Use fine motor skills for tasks such as reviewing documents, data entry, and equipment checks.
Lift and carry materials or equipment occasionally, up to 20lbs.
Wear personal protective equipment (PPE) as required in the production area.
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.