Quality Assurance and Quality Control Roles (Multiple Positions, NY) - Cipla : Job Details

Company:

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. We articulated our 2022 winning aspiration to double the number of patients we serve and hence, double the impact we create as a global pharmaceutical company. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division. We at Cipla are inspired by our purpose of 'Caring for Life' and strive to extend this philosophy to our associates and their families. We are looking for talented individuals to grow their careers while growing our business.

About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is 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 Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

Scope

The scope (content and statements) of this job description is designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job. This job description is not designed to provide an exact or exhaustive list of all job duties, tasks, skills, and qualifications. The intent of this job description is to be representative of the knowledge, skills, and abilities needed to satisfactorily perform the essential functions of the position satisfactorily and in accordance with the established performance expectations. The scope of the job may be modified with respect to the department, group, and on an individual assigned basis to a sometimes-specific testing group. Consideration of education, relevant training, and experience or a combination of all three may also result in further modification of the role.

InvaGen pharmaceuticals is looking for talent in the following areas at our two manufacturing sites in Fall River, MA and Central Islip, NY.

* Quality Assurance Inspector

* Quality Control Lab Technician

These are full-time positions, paid on an hourly basis, eligible for paid time-off and benefits for the following shifts:

* 7:00 AM - 3:30 PM

* 3:00 PM - 11:30 PM

* 11:00 PM - 7:30 PM

* 8:30 AM - 5:00 PM (Fall River, MA)

Summary of Responsibilities:

Quality Assurance:

* Perform in-process testing as per manufacturing batch record instructions.

* Conduct room and equipment checks prior to each stage of manufacturing.

* Execute acceptable quality limit (AQL) sampling and inspect in-process and finished product samples for the Quality Control Lab and ensure isolation of rejected material.

* Maintain records of standard weights and perform daily verification of balances.

* Reviewing engineering records such as temperature and humidity data calibration and PM records, Pest control records and contractor related functions.

* Assess online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step.

* Verify functionality of equipment, perform applicable testing and prepare reports for customer complaints.

* Monitor facility and product environmental operating conditions and Identify and report any non-conformances and/or discrepancies to management if applicable.

Quality Control:

* Perform sample management for all incoming raw materials, in-process, finished products and stability samples including but not limited to receipt, logging distribution and destruction.

* Coordinate chemical and reference standard inventory in the lab, verifying the expired chemicals and standards and discarding as per company procedures.

* Complete data entry and update all sample information in SAP as per company procedures.

* Maintain lab consumables supply and placing orders as per requirement.

* Oversee temperature and humidity monitoring for stability chambers.

* Conduct sample loading in stability chambers and submitting stability samples as per schedule.

* Assist in the shipment of the samples to contract labs as required.

* Provide general housekeeping in the QC lab and any other functional activity as assigned by management.

Educational, Skills & Experience Requirements and Preferences:

* Minimum high school diploma or equivalent education credential (ex. GED) required.

* Minimum of three (3) years' experience in quality assurance in a GMP pharmaceutical manufacturing operation.

* Two (2) years of work experience in a laboratory setting.

* Proficient user of Microsoft Office Programs to include Word, Excel, Outlook, PowerPoint, SAP and other business-related systems.

* Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university is preferred.

* Associates degree or higher in Chemistry, Laboratory Science, or related fields of study from an accredited institution is preferred.

* Must have current Good Manufacturing Practices (cGMP) knowledge.

* Effective interpersonal relationship skills and the ability individually and as a part a team.

* Must be a self-starter, demonstrate initiative and possess a positive professional attitude towards work.

* Must be willing to work overtime and on some weekends based on business need, if required.

Physical Requirements:

* Work standing or walking unassisted for 75% or greater of an 8-hour period.

* Ability to ascent/decent ladders; and able to lift up to 35 pounds.

* 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.

* Ability to wear appropriate PPE is required.

Locations:

Central Islip, New York, Hauppauge, New York or Fall River, Massachusetts

EEO Statement:

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.