QA Third Party Specialist

Job Title

Third-Party QA Associate

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)

$75,000 - $96,000

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

The scope of this focus will include but is not limited to:

•  Accountable for the oversight of work plan and deliverables of third party QA groups.

• Accountable for special projects and initiatives as directed.

• Facilitating and delivering systems, processes, and operations to manage drug, biologic, combination or device products produced by Third Party external manufacturing and packaging partners.

• Ensure ongoing compliance with quality and industry regulatory requirements.

This role will be part of the Cipla NY (Invagen) QA Team whose role is to ensure our patients receive medicine of the highest quality. We accept the trust patients place in us and we deliver quality medicines.

The general duties and responsibilities of this role include but are not limited to the following:

• Set work plans and schedules to align with business priorities.

• Direct work on an individual or group basis, as required.

• Work with Cipla USA and CMOs Departments regarding Quality issues and activities and to channel.

communications and escalations on both a global and regional basis for third party QA.

• Implement systems and processes that deliver compliant, safe, and effective products.

• Identify and lead projects for continuous improvements and efficiencies.

• Implement Quality KPIs that measure, analyze, and continuously improve the delivery of compliant, safe, and effective products.

• Participate in Quality Audits and Management Review.

• Evaluate Standards and Regulations against local SOPs to identify and eliminate gaps in policies.

• Conduct troubleshooting or investigation activities in a group setting.

• Ensure that tools are provided, and concerns are escalated, as appropriate.

• Ensure that the department teams are working in a safe way and following all safety rules and procedures.

• Ensure compliance to all data integrity and cGMP practices, procedures, and expectations.

• Ensure compliance and monitor the quality management systems of contract manufacturing facilities.
• Ensure continuous improvement in contract manufacturing facilities by conducting periodic audits to ensure compliance with respect to CFR, cGMP, ICH standards as applicable.

• Ensure the quality of product prior to release of batches for distribution.

• Participate in technology transfer activities at contract manufacturing facilities.

• Other specific duties and responsibilities as assigned.

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 of five (5) years of relevant experience in a Pharmaceutical FDA regulated industry in Quality Assurance and Compliance.
• Minimum of two (2) years’ experience of quality management in a pharmaceutical company.
• Minimum of three (3) years relevant experience directing work in a group setting and cGMP environment of manufacturing facility.
• Solid project management skills and experience is required.
• Must have working knowledge of cGMPs, CFR (210/211/ 820/4), ICH and applicable international.
• regulations/guidelines.
• Experience with Quality Systems such as electronic deviation and documentation management systems, SAP,
• and serialization as well as conducting Quality audits.
• Experience with external pharmaceutical manufacturing, packaging, testing and devices is desired.
• Experience with sterile products and devices desired.

Skills/ Competencies

• Strong computer skills including Microsoft Office Tools, Track Wise, Oracle and SAP.

• Proficiently speak English as a first or second language.

• Proficiently communicate and understand (read and write) scientific / regulatory based ‘work” in English.

• Bi-lingual in the Spanish language (speaking, writing, interoperating and translation) is preferred.

• Have excellent organization, learning and teaching skills required to work in teams.

• Ability to understand and analyze complex data sets.

• Strong desire towards continuous improvement.

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.

Must be willing to travel, work long hours, and some weekends based on relevant business needs if required.