Specialist, QC Microbiology 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.
Ferring is on a mission to transform the treatment of bladder cancer with a novel, first-in-class intravesical gene therapy that provides patients with an alternative to bladder removal surgery. Our Uro-Oncology team is growing with a variety of rewarding opportunities in commercial, medical affairs and technical operations. If you are energized by the prospect of bringing the benefits of cutting-edge science to meet the needs of patients, we may have the perfect role for you.
As the Specialist, QC Microbiology Compliance you will be responsible for leading compliance related activities and tasks for QC laboratory. This includes but not limited to conducting laboratory investigations including OOS/OOT, authoring technical protocols and reports, performing data review and trend analysis. Provide timely escalation of compliance related issues and assist management with other compliance related tasks as assigned.
This is your opportunity to play an important role in making available to patients a novel product that has the potential to revolutionize the treatment of bladder cancer!
Ferring US is Great Places to Work® Certified. Earning this certification means that Ferring US is one of the best companies to work for in the country. Our people are at the core of what makes Ferring a great place to work. Putting people first, strengthening our workplace culture, and ensuring that it is a safe, equitable, and welcoming place to work is a priority at Ferring, and it always will be.
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 thru, SOPs and Methods, deviation reduction initiatives, etc.
A Bachelor’s Degree in a scientific/technical discipline
A minimum of 3 years of industry experience with a least one in QC Laboratory settings required; Car-T experience preferred
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 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)
Lean Six Sigma concepts; Lean Labs;
Strong project management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.
Familiar with proper cGMP practices for QC laboratories and working knowledge of basic laboratory instrumental analysis.
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 $70,000 to $85,000, 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. Non-sales employees will be eligible for bonus up to 8% of their base salary, which is awarded to employees based on company and individual 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, parental leave, 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. 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.