Job Title: Quality Assurance Intern

FLSA Classification: Intern, Non-Exempt/Hourly

Work Location: Fall River, MA

Work Hours: General: 8:30AM - 5:00PM (may vary based on business needs)

Reports To: QMS Lead

Purpose:

InvaGen Pharmaceuticals, Inc. internship program is designed to offer a rewarding experience for the candidate, which will help add real world experience to their resume, as well as provide a fresh outlook and feedback on our current practices and processes. To be a strong candidate for an internship, you should understand the principles and concepts for the discipline for which you are seeking to intern. You should be collaborative, trustworthy, receptive to feedback, eager to learn, and have a positive attitude. An internship at Cipla is an opportunity to learn through real experiences.

Scope:

Invagen Pharmaceuticals is searching for experienced candidates for the position of Engineering intern.

The QA Intern is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing in compliance with established specifications. .As an intern, you will perform a variety of tasks, supporting various project managers and collaborating with team members. You will receive both on-the-job and formal training as well as mentorship, and exposure to plan production, and client interactions. You should be a motivated team player who can maintain efficiency and accuracy when multitasking. Interns gain a broader understanding of the business and through guest speakers, customer field experiences, facility tours, and individual / team-based experiences (i.e., one-on-one meetings, team lunch, customer meetings, etc.). Additionally, interns participate in numerous leadership development workshops intended to develop and refine professional skill sets.

Duties and Responsibilities include:

• Perform in-process testing (e.g. weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.
• Perform room and equipment checks (where applicable) prior to each stage of manufacturing following detailed written procedures.
• Perform AQL sampling and inspections as required.
• Prepare in-process and finished product samples (where applicable) for QC lab, following detailed documentation procedures and delivering them to QC lab.
• Maintenance of standard weights and perform daily verification of balances.
• Ensure the proper isolation of rejected material generated during batch process and accountability in the batch record.
• Monitor facility and product environmental operating conditions.
• Review of engineering records (temperature and humidity data calibration and PM records, Pest control records and contractor related functions).
• Review of online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing step.
• Verification of functionality of all the equipment and associated controls during the batch run.
• Perform applicable testing and prepare report for customer complaints.
• Identify and report any non-conformances/discrepancies to management if applicable.
• Other duties that management may assign from time to time.
• Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP).

Qualifications for Engineering Intern

• Must be currently enrolled in a 2-year or 4-year degree college program with focus on Industrial Manufacturing, or related field.
• Able to commit to a 6-8 week internship.
• Must be willing to work in a pharmaceutical setting.
• Proficiently speak English as a first or second language
• Proficiently communicate and understand (read and write) scientific work in English.
• Ability to understand and analyze complex data sets.
• Working knowledge of Microsoft Office programs and other scientific based software.
• Experience in Inhalation products (MDI) is a plus.

Skills

• Knowledge of good manufacturing practices and good documentation practices preferred.
• Ability to read, write and communicate effectively.
• Self-motivated, with the ability to work in fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Excellent organization skills with the ability to focus on details
• Basic computer skills (Word and Excel) - Intermediate
• Good basic math knowledge and excellent attention to details.

Physical requirements

• Must be willing to work in a pharmaceutical manufacturing setting.
• Must be willing to work some weekends based on business need as required by management.

GLOBAL COMPANY

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.

Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare. The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future. Driven by the vision, none shall be denied, Cipla's focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)

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

Cipla, Inc. and its subsidiaries are an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status.