Sr. Specialist, Data Review - R&D

Job Title:      Sr. Specialist, Data Review – R&D Injectables

Location:      Cherry Hill, NJ

Job Type:     Full time

Req ID:          10219

 

Description:

We continue to be 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 Injectables. In this role, you will be responsible for and accountable for the 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:

1. Ensures compliance with cGMP and good documentation procedure during the review process.

1. Audits regulatory pre-submission documents from the Analytical Research and Development (AR&D) and quality.
2. Perform AR&D technical, scientific, and compliance review of data and documentation generated by the AR&D group in support of regulated studies.
3. Identify deviations, OOS and OOT associated with AR&D data as applicable.
4. Issue AR&D review observations and work closely with the scientific staff to ensure data integrity.
5. Informs the manager immediately of any critical data integrity issues or data irregularity.
6. 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.

 

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

Minimum Required:

•           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.

SKILLS

Expert computer skills with the ability to enter data into and retrieve information from various software progra