QA Inspector II 2nd Shift

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Ciplas U.S. Subsidiaries or Affiliates.

Job Title: QA Inspector II - 2nd Shift
FLSA Classification: Full-Time Non - Exempt Professional
Work Location: Fall River MA
Work Hours: second Shift: 3:00 PM 11:30PM (may vary based on business needs)
Reports To: Quality Control Manager
Salary Range:$26 - $33

Job Purpose:

The purpose of the QA Inspector position is to monitor and ensure shop floor activities and ensure product quality is maintained throughout all phases of the manufacturing and packaging process in compliance with established specifications and standard operating procedures (SOPs).

Duties and Responsibilities:

The QA Inspector (MDI) position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team. The essential and typically expected job duties for this position include but are not limited to the following:

• Working knowledge of shop floor QA activities (Line clearance in-process checks sampling calibration and verification of equipments).
• Perform line clearance in-process testing as per batch record instructions.
• Review of batch records.
• Preparation issuance and review of logbooks.
• Conduct room and equipment checks (where applicable) prior to each stage of manufacturing by following detailed written procedures.
• Execute sampling and inspections as required.
• Inspect in-process and finished product samples (where applicable) for the Quality Control (QC) Lab.
• Maintain records 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 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 the functionality of all the equipment and associated controls during the batch run.
• Identify and report any non-conformances and/or discrepancies to management if applicable.

Education and Experience:

• Minimum Bachelors degree in Pharmaceutical science or Equivalent.
• Advanced vocational training or education in pharmaceutical manufacturing industrial management or related field of study from an accredited college/university is preferred.
• Experience in quality assurance in a cGMP pharmaceutical manufacturing operation and work environment is preferred.
• Minimum of 2 years experience in quality assurance in a cGMP pharmaceutical manufacturing operation and work environment.
• Experience in MDI or combination products is preferred.
• Proficient user of personal computer hardware and software applications such as Microsoft Office tools SAP and other business applications.
• Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Proficiency in the English language to include usage spelling grammar and punctuation.
• Must have current Good Manufacturing Practices (cGMP) knowledge.
• Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
• Must have strong organization and leadership skills (written verbal and presentation).
• Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.

Working conditions

This role works in a cGMP 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 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.

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 always wear appropriate personal protective equipment when required.
• Sitting at a desk and/or working at a computer or other screen 75% or greater of an 8-hour period.

Professional and Behavioral Competencies:

• Must be willing to work in pharmaceutical manufacturing and packaging quality assurance.
• Must be willing and able to work any assigned shift ranging from first or second shift. Work schedule may be Monday to Friday.
• Must be willing to work some weekends based on business needs as required by management.
• No remote work available.

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 Indias 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 Ciplas 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.

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.