Job Title: Quality Assurance 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

Purpose:

This position requires a strong analytical chemistry/lab background and experience. The job duties for this position include but are not limited to the following:

Scope:

The Quality Assurance (QA) Senior Specialist position is an individual contributor role and reports to the Quality Assurance Manager for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary located at Fall River, MA.

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

• Confirming and ensuring the compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports.
• Monitoring and ensuring of current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation to ensure adherence to procedure.
• Verifying the standard operating procedures (SOPs) and test procedures.
• Verifying process validation and characterization-related documents.
• Coordinating with the Regulatory Affairs (RA) and Analytical Laboratory Teams to arrange required documents for timely submission as part of new and existing abbreviated new drug applications (ANDAs).
• Maintaining all the incoming documents with proper tracking, recording, storage and archival of the documents.
• Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor for necessary improvements in the identified areas.
• Actively participating in laboratory investigations and incidents as well as ensuring the proper compliance.
• Evaluating and confirming the compliance related to raw materials, inprocess and finished product analytical documents.
• Conducting random internal audits in analytical lab and ensuring the compliance.
• Assessing and implementing of Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect.
• Performing other departmental and cross-functional projects and assignments given by the manager.

Education and Experience

• Possess a bachelor's degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution. Master's degree in the above and/or related fields of study as noted above preferred.
• A minimum of eight (8) years of relevant work experience in a pharmaceutical manufacturing setting within the Quality function.
• Experience using statistical software packages is a plus.
• Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.
• 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) 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

• Proficiently speak English as a first or second language.
• Must be a self-starter and demonstrate initiative to seek additional training or direction as needed.
• Must be willing and able to work any assigned shift ranging from first or second shift; work schedules may be Monday to Friday.
• 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 a fast-paced manufacturing environment and handle multiple tasks simultaneously.
• Excellent organizational skills with the ability to focus on details.

Work Schedule and Other Position Information:

• Must be willing to work in a pharmaceutical manufacturing setting.
• Must be willing and able to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.
• Must be willing to work some weekends based on business needs as required by management.
• Relocation negotiable.
• No remote work available.
• This role works in cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required, which may include uniforms, lab coats, safety glasses, respiratory protective equipment, hearing protection, etc.
• The role may be assigned on a work-shift basis where required (Day, Evening, Night). Weekend or Holiday work may be requested or required based on business needs.

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.