Senior Analyst, QA Stability (Pharmaceuticals)

Senior Analyst, QA Stability (Pharmaceuticals)

Hauppauge, NY (+Adams+Avenue+Hauppauge+NY+USA+11788)

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Description

Position Summary :

The QA Stability Sr. Analyst is primarily responsible for being the technical subject matter expert for the stability and retention program which includes drugs, dietary supplements and food products. The Sr. Analyst will develop stability protocols, produce product stability and shelf-life reports in support of product expiry, perform stability assessments, and support the stability and retention sample inventory management aspect of the program.

Responsibilities : Responsibilities include, but are not limited to :

Design, execute, and document stability studies to assess product shelf-life and storage conditions. Approve related protocols as applicable.

Write and / or review related Standard Operating Procedures. Approve such SOPs as applicable.

Write and / or review Deviation Reports related to the stability program.

Analyze and interpret stability data and documenting results in compliance with regulatory standards.

Assess the stability impact of changes outlined in Management of Change.

Calculate product shelf life, prepare shelf-life reports.

Troubleshoot analytical and product problems, including investigating out-of-specification or unexpected results

Provide stability reports to customers and for APR reports.

Support the management of retain and stability samples in storage areas / chambers.

Support the monitoring of stability chambers and the stability room and ensure units are operational and within specification.

Maintain and support any related electronic documentation and sample management systems.

Collaborate with cross-functional teams, such as quality assurance, manufacturing, regulatory affairs, business development, and account services to ensure product stability and quality, and align with customer expectations.

Support audits, inspections and requests from health authorities, third parties such as UL, and customers.

Lead continuous improvement initiatives in all aspects of the stability program.

Other responsibilities as assigned by management.

Requirements

Education and Experience :

Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific field. Master’s degree a plus.

Proven experience (typically 5+ years) in stability studies within the pharmaceutical, OTC, and dietary supplement industries.

Skills. Knowledge and Abilities :

Strong understanding of cGMP, GLP, and ICH guidelines related to stability testing.

Proficiency in analytical techniques used in stability testing, including, but not limited to, HPLC, GC, and dissolution testing. Expertise in data analysis, interpretation of stability data, and experience with statistical software packages (e.g. Minitab).

Excellent written and verbal communication skills, including the ability to write clear and concise protocols, reports, and regulatory documents.

Demonstrated analytical and problem-solving skills, with keen attention to detail.

Ability to work both independently and collaboratively within a team environment.

Adaptability and flexibility to meet changing project needs and timelines in a dynamic environment.

Skilled in using Microsoft Office suite. Familiarity with Microsoft Access database is a plus.

Ability to interact, and fluently work in electronic ERP, QMS, LIMS for managing stability data, and similar computer systems.

Physical Demands :

Required to use hands / fingers to handle documentation, file, and operate computer controls.

While performing the duties of this job, the employee is regularly required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs or walk for long periods. The employee may lift and / or move up to 50 lbs.

Specific vision abilities required include close vision, color vision, and ability to focus.

Work Environment :

Required to be present in-house to provide immediate department management, and collaborate with customers, department directors, direct reports, peers, and supervisors daily.

Work environment in laboratory and production operations facilities include close proximity to heavy machinery, loud noises, and pharmaceutical powders.

Potential to move between production operations sites / areas to complete job functions; regular, ongoing travel throughout geographic areas on a continual basis as normal scope of role requiring use of personal vehicle.

Employee work hours / schedule and / or shift are subject to change based on business needs and Management discretion.

Supervisory Responsibilities :

• May supervise QA Stability employees.

Personal Protective Equipment or Attire Required for Position :

Pay Range :

$70,000 - $90,000 per year