QA Associate III - Hauppauge, United States - Cipla

Description

About Cipla

Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India's pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world.

Driven by the purpose 'Caring for Life', Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.

InvaGen Pharmaceuticals, Inc.

InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla's respiratory business in the United States.

Job Title

Analytical QA Associate III

Organization Name

InvaGen Pharmaceuticals

Location

550 South Research Place Central Islip, NY 11722

7 Oser Ave, Hauppauge, NY 11788

Employment Type

(Hourly/ Full Time)

Full Time - Salaried/Exempt

Salary Range

(Base/ Hourly)

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 purpose of this position is to serve as an Analytical Quality Assurance (AQA) Associate. This role will report to the Section Head of Analytical QA or other senior leaders in the Quality organization at InvaGen Pharmaceuticals, Inc.

This role will be part of the Cipla NY (Invagen) Quality Control (QC)/Analytical 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:

• Verify analytical equipment, qualification/calibrations, and ensure compliance before usage.
• Review and ensure compliance of analytical documents related to in-process, finished product, stability studies, etc.
• Verify the validation processes and characterization.
• Execute and follow standard protocols.
• Utilize laboratory compliance software's such as "Empower", "Potentiometry", and other softwares used in an analytical laboratory setting.
• Prepare and review standard procedures in line with guidelines.
• Review and identify gaps within the system during routine monitoring and inform the supervisor of any potential areas of improvement within the identified areas.
• Conduct laboratory investigations and review incidences.
• Ensure compliance to all data integrity and cGMP practices, procedures, and expectations.
• 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.
• Must have a minimum of five (5) years of relevant experience in Analytical QA.
• 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

• Must have Analytical QA experience within the pharmaceutical industry.

Skills/ Competencies

• Knowledge of UV, HPLC, DSC, and other tests.
• Must be competent in cGMP.
• Know and understand how to create, read, and interpret 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.

Equal Opportunity Employer

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter.

About the Salary/ Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.