QA Data Reviewer

· Review and approve method validation/verification protocols and reports.

· Audit Analytical Data associated with research and development, method validation, raw material testing, stability testing and commercial finished drug product testing.

· Audit executed batch records.

· Ensure tests have been completed as per applicable methods and/or standard operating procedures.

· Verify that all equipment used to perform testing is calibrated

· Verify that all reagents and solutions used to perform testing are prepared correctly and within specification and/or solution stability where applicable.

· Verify associated calculations are correct.

· Obtain corrections and clarification where needed.

· Collaborate with laboratory personnel to ensure that data is reviewed in a timely manner

· Author and review SOPs upon request as they relate to responsibilities.

· Audit internal Quality Management Systems as delegated

· Audit external Contract Laboratories as delegated.

· Support investigation of LIRs where applicable.

· Perform receipt/reconciliation of Analytical samples used for testing.

· Assist with site registrations (FDA, NJDEP, EPA, etc.)

· Administrative duties as requested by Quality Assurance Management.

Solaris Pharma Corporation is seeking a Quality/Analytical Data Reviewer with 2-3 years’ experience within the pharmaceutical industry., · BS/BA degree in chemistry, biology, allied health, or chemical engineering.

· At least 2-3 years’ experience in pharmaceutical industry and/or relative experience

· Experience with IC, IR, UV, HPLC and GC

· Experience performing analytical data review

· Previous Analytical laboratory/testing experience

· Experience performing batch record review a plus (nor a requirement)

· Knowledge of cGMPs and GLPs

· ASQ or relevant certifications are a plus in lieu of experience

· Must be a collaborative self-starter

· Must be able to work independently and meet required timelines

· Must be able to work in a fast-paced environment

· Excellent communication/soft skills and the ability to negotiate

· Exhibits skills to think outside of the “box”

· Proactive and takes initiative in the absence of the Direct Manager

Pulled from the full job description

• Referral program
• 401(k)
• Health insurance
• 401(k) matching
• Paid time off
• Vision insurance
• Health savings account, * 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Solaris Pharma Corporation is a specialty pharmaceutical company focused on the development and commercialization of high-quality, complex generic and specialty medicines. Backed by deep expertise across the full product development lifecycle and a highly skilled scientific team, Solaris operates with streamlined, efficient processes that reduce development timelines and costs-without compromising quality.