Quality Assurance Supervisor

Job Title

DPI QA Supervisor

Organization Name

InvaGen Pharmaceuticals, Inc.

Location

7 Oser Avenue,

Hauppauge, NY

Shift

General (8:30AM – 5:00PM)

Employment Type

Full Time

Salary Range (Base/salary)

$74,600 – $90,000

Benefits

In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance – medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) – vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid family leave, employee discounts, and other benefits.

Purpose

The purpose of this position is to serve as a Quality Assurance (QA) Supervisor supporting the QA Department.

The QA Supervisor is responsible for monitoring and ensuring product quality is maintained through all phases of manufacturing and packaging in compliance with established procedures.

Responsibilities/ Accountabilities

· Manage daily performance and attendance of Quality Associates. Provide work direction and guidance on issues relating to Quality and schedule attainment.

· Oversee, and perform as necessary, all Incoming, Dispensing, In-Process, and Final Inspection activities.

· Supervise associates in a manner that fosters a safe work environment and self-directed team approach. Identify, arrange, and/or provide training to ensure a safe, efficient, quality work environment with a focus on continuous improvement.

· Promote an atmosphere of diversity, open communication, and trust, affording opportunities for training and growth.

· Facilitate communication, coordination, and conflict resolution within and among work groups.

· Provide leadership to associates in all areas, including hiring, performance management, coaching, counseling, and corrective actions.

· Monitor/track QA department metrics. Help to identify, prioritize, and implement continuous improvement initiatives to drive year-over-year departmental improvements

· Assist in reviewing all product non-conformances and determining appropriate corrective actions.

· Assists management with the development of new and revised SOPs, executes validation & qualification studies, performs investigations and other assignments as required.

· Handles Change Controls, Deviations and CAPAs through quality management tools such as TrackWise.

· Monitors and ensure that batch records are reviewed per manufacturing / packaging requirements.

· To take daily Quality rounds at shop floor to ensure shop floor is maintained in state of compliance and per GMP requirement.

· Report, escalate to Manager quality assurance about daily shop floor activities and any discrepancy during batch manufacturing and packing.

· Ensure completion of individual and departmental training assigned and follow company policies, safety requirements, cGMP and SOP’s

· Other duties [additional support] that management may assign from time to time.

Education Qualifications

The ideal candidate’s minimum qualifications will include:

· A bachelor’s degree (BS or BA) in pharmaceutical manufacturing or related technical/physical science from an accredited college/university is required.

· A master’s degree in a field to study relevant to the position is preferred.

· Minimum of 5-10 years of relevant experience in a Pharmaceutical FDA regulated industry in (DPI, MDI or Injectables preferred).

Experience

· Minimum of two (2) years’ supervisory experience.

· Experience with Quality Systems such as electronic deviation and documentation management systems, SAP, and serialization as well as conducting Quality audits.

· Experience with external pharmaceutical manufacturing, packaging, testing and devices is desired.

Skills/ Competencies

· Must have current Good Manufacturing Practices (cGMP) knowledge and 21 CFR Part 820.

· 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.

· Basic computer skills (Microsoft Word, Power and Excel) and Trackwise, 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.

· 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.

Physical Requirements

· This role works in a current Good Manufacturing Practice (cGMP) office, laboratory and manufacturing environment, where personal protective equipment (PPE) may be required, which may include uniforms, lab coats, safety glasses, respiratory PPE, hearing protection, etc.

· Work with or around materials commonly found in a pharmaceutical laboratory or manufacturing facility may be required.

· Sitting at a desk and/or working at a computer or other “screen” 75% or greater of an 8-hour period may be required.

· Relocation negotiable.

· Must be willing to work long hours and some weekends based on a relevant business need, if required.

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.