Quality/Analytical Data Reviewer

Company Overview

Solaris Pharma Corporation specializes in developing and marketing complex generic and specialty pharmaceuticals. With expert knowledge covering the entire product lifecycle and a skilled scientific team, the company streamlines processes to shorten development time and reduce costs while maintaining high standards. Their expanding portfolio includes various dosage forms such as sterile, dermatological, and solid oral products, each involving unique challenges in formulation, process, regulatory compliance, stability, and scale-up.

Role Overview

We are looking for a Quality/Analytical Data Reviewer with 2 to 3 years of pharmaceutical industry experience to join our team. This role involves comprehensive review and approval of analytical data and documentation, ensuring compliance with regulatory and quality standards.

Key Responsibilities

• Review and approve protocols and reports related to method validation and verification.
• Audit analytical data from research and development, method validation, raw material and stability testing, as well as commercial finished product testing.
• Examine executed batch records to confirm compliance.
• Verify test completion according to applicable methods and standard operating procedures.
• Ensure calibration of equipment used in testing.
• Confirm that reagents and solutions are properly prepared within specifications and maintain solution stability when applicable.
• Validate accuracy of related calculations and obtain necessary corrections or clarifications.
• Collaborate with lab staff to ensure timely data review.
• Draft and review Standard Operating Procedures (SOPs) as needed.
• Conduct audits of internal Quality Management Systems and external contract laboratories as delegated.
• Support investigations into Laboratory Investigation Reports (LIRs) when necessary.
• Manage receipt and reconciliation of analytical samples used in testing.
• Assist with site registrations including FDA, NJDEP, EPA, and others.
• Perform administrative tasks assigned by Quality Assurance Management.

Qualifications

• Bachelor's degree in chemistry, biology, allied health, or chemical engineering.
• 2 to 3 years of relevant experience in the pharmaceutical sector or related fields.
• Proficiency with analytical instrumentation including Ion Chromatography (IC), Infrared Spectroscopy (IR), Ultraviolet Spectroscopy (UV), High Performance Liquid Chromatography (HPLC), and Gas Chromatography (GC).
• Hands-on experience in analytical data review and laboratory testing.
• Knowledge of batch record review is advantageous, though not mandatory.
• Familiarity with current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs).
• Certifications such as ASQ or related credentials are a plus in place of experience.
• Strong collaboration skills and self-motivation.
• Capability to work independently and meet deadlines in a fast-paced environment.
• Excellent communication and interpersonal skills, including negotiation abilities.
• Creative problem-solving skills and proactive initiative-taking in absence of direct supervision.