Title:  Deviation Specialist

Job Title: Deviation Specialist

Location: Cherry Hill, NJ

Job Type: Full-Time

About Us:

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ purpose is to put better health within reach, every day for millions of patients around the world. We are a trusted, reliable partner and dependable source of over 760 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe. Through our global footprint of 30+ manufacturing plants, 8+ R&D centers, and 9,000+ empowered employees, we are committed to making high-quality medicines accessible to the people who need them.

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Deviation Specialist to join our team.  In this role, you will be responsible for managing the day to day non-conformances in manufacturing and quality environments. Investigate deviations by assessing product impact, identifying root causes, and implementing corrective/preventative actions. You will work closely with quality and manufacturing teams in ensuring compliance with regulatory requirements and internal quality standards to maintain product quality and safety

Key Responsibilities:

• Investigate any non-conformances from sterile injectable production processes and ensure timely closure of quality events by assessing product impact, identifying root causes, and implementing corrective/preventative actions.
• Write annual product reviews.
• Understand the scientific principles for manufacturing parenteral drug products, including the interaction of chemistry, equipment, aseptic processes, and container closure systems.
• Use technical writing skills to produce clear, concise, and thorough investigation reports.
• Work closely with various departments to identify and mitigate technical issues.

• Revise and train individuals on the SOP's relating to the investigation process.  Participates in the development and delivery of training/refresher courses in quality systems and or GMP regulations and requirements and consultation as necessary.

• Individual to provide direction for process improvements or preventative measures to avoid or minimize process deviations consistent with business requirements.

Qualifications:

We value the skills and experiences candidates bring to the table.  While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• Bachelor’s degree in the sciences or engineering
• 1-3 years experience working in a pharmaceutical manufacturing facility.

Preferred Qualifications:

• Strong Chemistry or Microbiology background
• Experience writing technical documents including, but not limited to, manufacturing deviations/investigations, change controls, and customer complaints.

Compensation:

Base Salary: $56,950 to $95,000 annually.  The compensation for this position will be determined during the interview process and will vary based on multiple factors, including, but not limited to, work location, prior experience and job-related knowledge, relevant skills and expertise, current business needs, and market factors. The Talent Acquisition team can provide more details about the specific salary range for the job location during the hiring process.

What We Offer*:

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay.  Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date).  Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave

*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment.  Benefits are subject to change as well as specific plan or program terms.

Recruiters:

Please note that Hikma has a set roster of approved recruiters for specific roles agreed to in advance and does not accept unsolicited resumes or calls from third-party recruiters or employment agencies regarding open positions.  In the absence of a signed agreement and approval from Hikma’s Human Resources department to submit resumes for a specific position, Hikma will not approve, nor will be under an obligation to make, any payment to such non-approved third-parties in the event a candidate they refer is hired by Hikma.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer.  Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.