Job Title

QA Validation Associate II

Organization Name

InvaGen Pharmaceuticals

Location

550 South Research Place Central Islip, NY 11722

Employment Type

(Hourly/ Full Time)

Full Time - Salaried/Exempt

Salary Range

(Base/ Hourly)

$65,000 - $72,500

Benefits

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits

Work Hours/ Shift/ Remote

General Shift: 8:30 AM - 5:00 PM

Responsibilities/ Accountabilities

JobPurpose

The QA Validation Associate role is responsible for providing Quality Assurance support for receiving/ releases GMP documentation of bulk drug substances and finished drug products. Responsibilities include but are not limited to GMP documentation review and supporting other QA functions as needed. In this role, the individual is responsible for continuously monitoring systems and procedures to ensure compliance with applicable regulatory and industry standards, and to identify areas of opportunity and quality improvements.

Duties and responsibilities

The general duties and responsibilities of the "QA associate II" include but are not limited to the following:

• Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices (GDP), including but not limited to: executed batch records, master batch records, product labels, and product specific documents
• Independently executes batch record review for completeness, accuracy and cGMP compliance.
• Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product.
• Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs
• Compile and report performance metrics for Batch Review and Release
• Contributes to process improvement of batch records and associated processes (e.g. turnaround times) to ensure all QA batch disposition deadlines are met.
• Ability to quickly process complex information and make critical decisions with limited information required.
• Oversee status of batches through disposition/release process and remove barriers, communicate escalations as appropriate.
• Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities.
• Prepare reports and keep upper-level management informed of progress, Act as QA reviewer for investigations, deviations and CAPAs appropriate and designated by QA Management.
• Performs duties under limited supervision and according to standard operating and manufacturing procedures.
• Collaborates within Manufacturing to resolve document discrepancies or errors as it relates to Good Documentation Practices.
• Perform tasks in a manner consistent with all Cipla policies including safety (EHS), quality systems and cGMP requirements.
• Understand risks and delays to batch release and communicate appropriately.
• Identify and participate in internal quality improvement initiatives: evaluate internal processes, suggest/design/ implement improvements, create/revise relevant SOPs.
• Participate in site and corporate quality and process improvement initiatives. Represent QA on project teams and represent the Batch Disposition QA perspective as needed.
• Works in a collaborative team setting within the Batch Disposition team, within the quality department and with quality counterparts including Manufacturing Operations, Technical Support, Supply Chain and Planning.
• Interacts with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging, and release of products.
• Other duties, as necessary

Education Qualifications

• A minimum of a Bachelor's degree in a relevant field of study from an accredited institution.
• Knowledge of pharmaceuticals, manufacturing, utility, lab systems, and equipment, preferably in solid or semisolid dosage forms.
• General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical design/commission/validate processes and how they relate to regulatory requirements and cGMP regulations with U.S. FDA.
• Knowledge of SAP System (Preferred)

Experience

• Minimum 3-5 years of pharmaceutical experience.

Physical Requirements

• Sitting at and/or working at a computer or other "screen" 75% or greater of an 8-hour period.

Other Information

• No remote work available.