QA Operations Specialist

Job Title : Quality Assurance Operation Specialist

FLSA Classification : Professional, Exempt


Work Location : Fall River, MA


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

Reports To : Quality Assurance Manager

Salary Range: $76,000 - $103,000

Purpose:

The QA operation specialist (MDI) position is an individual contributor role and a member of the InvaGen Pharmaceuticals Plant Quality Team.


The QA operation specialist (MDI) monitors and ensures validation and qualification of facility, utilities, equipment's, processes and ensure product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs) and provide guidance to QA associates.

Duties and Responsibilities:

The job duties for this position include but are not limited to the following :

• Review of batch manufacturing/packaging record.
• Review of engineering records such as temperature and humidity data calibration and PM records, pest control records and contractor related functions.
• Review and approval of manufacturing/engineering non-conformances.
• Review and approval of manufacturing/engineering change control, deviation investigation and CAPAs.
• Review and approval of manufacturing/engineering validation and qualification documents.
• Provide daily/weekly updates to shop floor and management regarding the quality highlights/concerns.
• Create lessons learned for training as communication mechanism to shop floor personnel.
• Perform applicable testing and prepare reports for customer complaints.
• Identify and report any non-conformances and/or discrepancies to management if applicable.
• Verify functionality of all the equipment and associated controls during the batch run.
• Act as quality lead for all shop floor questions / concerns.
• Backup for shop floor QA Associates.
• Complete other duties or participate in project work as assigned by management.

Education and Experience

• Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university.
• Bachelor's degree in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university is preferred.
• Minimum of five (5) years' experience in quality assurance in a cGMP pharmaceutical manufacturing operation and work environment.

• Experience in MDI or combination products is preferred.

• Minimum of five (5) years' experience in quality assurance in a cGMP pharmaceutical manufacturing operation environment.
• Current, working knowledge of quality assurance (QA).
• Strong knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good Distribution Practices (GDP), etc.

Technical Knowledge and Computer Systems Skills

• Understanding of machines used in pharmaceutical manufacturing.
• Must be able to influence decision making and facilitate completion of work towards the achievement of the business plan and goals.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Capable of conducting troubleshooting, investigations and root cause identification and analysis.
• Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
• Must be proficient in computer skills and software applications such as Microsoft Office tools.
• Experience using SAP business system and applications is a plus.
• Experience in Inhalation products (MDI) or Combination products is a plus.

• Ability to work in a fast-paced, dynamic environment within a manufacturing operation setting.
• Must be able to communicate clearly and concisely across all levels of the organization and possess a solid command of English language communication skills verbally, written, and interpersonally.
• Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.
• Must be able to work under minimal supervision and able to work independently and in a team environment.
• Must be able to exercise appropriate professional judgment on matters of significance.

Professional and Behavioral Competencies

• 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.

Work Schedule and Other Position Information :

• 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.
• 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 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.

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.