Shire Jobs

Job Title

Senior QA Manager

Organization Name

InvaGen Pharmaceuticals

Location

550 South Research Place Central Islip, NY 11722

600 Old Willets Path Hauppauge, NY 11722

Employment Type

(Hourly/ Full Time)

Full Time - Salaried/Exempt

Salary Range

(Base/ Hourly)

$95,000 - $117,500

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

8:30 AM - 5:00 PM

Responsibilities/ Accountabilities

• Ensure employees and processes comply with current Good Manufacturing Practices and company procedures at Cipla USA OSD plants.
• Support of site and company-wide objectives through the reporting of department Key Performance Indicators
• Oversee Unit-3 site operation QA activities including both Manufacturing and Packaging.
• Follow standard operating procedures and execute change controls to support business and quality objectives.
• Establishes and maintains cooperative cross-functional relationships with peers in Quality, Operations, Technical Support, Regulatory Services, Research & Development, and Supply Chain to meet site and corporate objectives.
• Support audit readiness and assisting with audit preparation, regulatory inspections, and customer audits.
• Support a quality and compliance focused culture which embraces RFT and CI expectations in partnership with the site leaders.
• Maintain working knowledge of government and industry quality assurance regulations and standards.
• Establish and maintain effective cross functional relationships.
• Supports regulatory inspections and customer audits for the site
• Manage the corporate and site programs (i.e. self-improvement audits) to assess and improve the state of compliance of cGMPs.
• Manage Site Master File and Quality Manual program.
• Support Change Control & Corrective/Preventive Action commitments resulting from internal audit, customer audit and agency inspection observations to verify implementation and effectiveness.
• Communicates shopfloor metrics (deviations, change controls, CAPA etc.) trends to leadership
• Provide leadership to the Quality and Compliance function, manages, and provides development support to department personnel
• Provide leadership and coaching to shop floor quality team members.

Education Qualifications

• A Bachelor's degree (BS or BA) in Chemistry or related technical/physical science from an accredited college/university is required. A master's degree in a field to study relevant to the position is preferred.
• Experience working in pharmaceutical QA is preferred.
• Proficiently speak English as a first or second language.
• Proficiently communicate and understand (read and write) scientific / regulatory based 'work" in English.
• Have excellent organization, learning and teaching skills required to work in teams.
• Strong desire towards continuous improvement.
• Know how to use Microsoft Office programs and other scientific based software

Experience

• Minimum ten (10) years of experience in quality operations in a pharmaceutical (cGMP/FDA regulated) industry.
• Minimum five (5) years of management experience.
• Prior experience in Oral Solid Dosage Manufacturing.
• Knowledge of regulatory requirements as they pertain to pharmaceutical manufacturing and related GMP as per company policies and SOPs.

Physical Requirements

• Work standing or walking unassisted for 75% or greater of an 8-hour period.
• Unassisted lifting up-to 10 kg, may be required.
• Able to wear appropriate personal protective equipment at all times, when required.
• Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period.

Other Information

This role works in a cGMP laboratory or manufacturing environment, where personal protective equipment is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc. Work with or around solvents, powders, or other materials commonly found in a pharmaceutical laboratory or manufacturing facility is required.

The role may be assigned on a work-shift basis, where required (Day, Evening, Night). Weekend or Holiday work may be requested or required.

No remote work available. Relocation available.