Job Title: Sr. Specialist, Data Review – R&D Quality
Location: Cherry Hill, NJ (100% Daily onsite attendance)
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 Sr. Specialist, Data Review – R&D Quality to join our team. In this role, you will be responsible for critical review of pre-submission raw data and reports ready for regulatory submission to the US FDA. Responsibilities include the review of assigned pre-submission data and reports by using department SOPs and analytical methods to ensure Data Integrity, Reliability, Accuracy, and Traceability of any submitted data.
Key Responsibilities:
- Onsite, predictable attendance required.
- Ensures compliance with cGMP and good documentation procedure during the review process.
- Audits regulatory pre-submission documents from the Analytical Research and Development (AR&D) and quality.
- Perform AR&D technical, scientific, and compliance review of data and documentation generated by the AR&D group in support of regulated studies.
- Identify deviations, OOS and OOT associated with AR&D data as applicable.
- Issue AR&D review observations and work closely with the scientific staff to ensure data integrity.
- Informs the manager immediately of any critical data integrity issues or data irregularity.
- Completes the audit tasks within the specified timeframe without compromising the quality of the audit.
- Performs any other responsibilities which are required as assigned by the manager.
- Other duties as assigned.
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:
EDUCATION
Minimum: A specific educational background and previous relevant experience are required.
- Requires a bachelor’s degree in chemistry or closely related field and at least 5 years of FDA regulated cGMP analytical development or related laboratory experience, or
- Master’s degree in chemistry or closely related field with 3 years of FDA regulated cGMP analytical development or related laboratory experience, or
- Ph.D. in chemistry or closely related field and 2 years of FDA regulated cGMP analytical development or related laboratory experience.
EXPERIENCE/SKILLS:
- Knowledge in pharmaceutical cGMP requirements, ICH/US FDA guidelines, Laboratory test procedures, raw material analyses, method validation guidelines, analytical method transfers, finished products and stability testing procedures, method validation protocols/reports, COAs, product development reports, and Quality overall summaries.
- Knowledge in pharmaceutical analytical technologies.
- Proficient in MS Office applications (Word, Excel).
- Proficiency in LIMS, Empower 3 CDS and Quality Management software packages.
- Ability to monitor, coordinate and prioritize work in an effective and efficient manner, with capacity to manage simultaneous projects within a set timeline; ability to continuously make an assessment of the workload and suggest any support required on need basis.
- Must be a self-motivated, proactive team player with positive interaction with colleagues and stakeholders to ensure work ethics, teamwork, and discipline.
- Conduct oneself in a professional manner in alignment with corporate values.
- Ability to work and interact successfully in a global, diverse and dynamic environment.
- Demonstrates excellent interpersonal communication skills: verbal, written and presentation skills.
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.
Job Type: Full-time
Pay: $85,000.00 - $110,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Experience level:
Schedule:
- 8 hour shift
- Monday to Friday
Work setting:
Application Question(s):
- Will you now, or in the future require Hikma to sponsor you to obtain/continue employment to work in the United States (e.g. H1-B Visa)?
- Do you have a minimum of two (2) years of FDA regulated cGMP analytical development or related laboratory experience?
Education:
Ability to Commute:
- Cherry Hill, NJ (Required)
Ability to Relocate:
- Cherry Hill, NJ: Relocate before starting work (Required)
Work Location: In person