Quality Assurance Analyst

Job Title: Quality Assurance Analyst - On-the-floor Inspector

FLSA Classification: Full-Time, Exempt Professional

Work Location: Fall River, MA

Work Hours: General: 8:30AM – 5:00PM (May very based on business needs)

Reports To: Quality Assurance Manager

Salary Range: $65,000 - $90,000 (DOE)

The Quality Assurance Analyst monitors and ensures that product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs

• ).Perform in-process testing (e.g. weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instruction
• s.Conduct room and equipment checks (where applicable) prior to each stage of manufacturing by following detailed written procedure
• s.Execute acceptable quality limit (AQL) sampling and inspections as require
• d.Inspect in-process and finished product samples (where applicable) for the Quality Control (QC) Lab and following detailed documentation procedures to deliver the results to the QC La
• b.Maintain records of standard weights and perform daily verification of balance
• s.Ensure the proper isolation of rejected material generated during batch process and accountability in the batch recor
• d.Monitor facility and product environmental operating condition
• s.Review of engineering records such as temperature and humidity data calibration and PM records, Pest control records and contractor related function
• s.Assess online batch records in terms of completeness of signatures, entries, and actual reconciliation / yields prior to initiation of next processing ste
• p.Verify functionality of all the equipment and associated controls during the batch ru
• n.Perform applicable testing and prepare reports for customer complaint
• s.Identify and report any non-conformances and/or discrepancies to management if applicabl
• e.Complete other duties or participate in project work as assigned by managemen

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.EDUCATION AND EXPERIENCE QUALIFICATI

• ONSAdvanced vocational training or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university.is preferr
• ed.Minimum of three (3) years’ experience in a quality assurance in a GMP pharmaceutical manufacturing operation and work environm
• entExperience in MDI or parentals prefer
• redMust be authorized to work permanently in the United States without sponsors
• hipMust be able to work on-s

ite
KNOWLEDGE, SKILLS, AND ABILI

• TIESProficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, and other business applicati
• ons.Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and go
• als.Effective interpersonal relationship skills and the ability to work in a team environm
• ent.Proficiency in the English language to include usage, spelling, grammar and punctuat
• ion.Must have current Good Manufacturing Practices (cGMP) knowle
• dge.Must have strong attention-to-det
• ail.Must be a self-starter and demonstrate initiative with seeking additional training or direction as nee
• ded.Must have strong organization and communication skills (written, verbal, and presentati
• on).Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadli

nes.
GLOBAL CO

MPANYCipla 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 w

orld.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 w

orld.
EEO Stat

ement: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 s

tatus

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SCOPEThe scope (content and statements) of this job description is designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job. This job description is not designed to provide an exact or exhaustive list of all job duties, tasks, skills, and qualifications. The intent of this job description is to be representative of the knowledge, skills, and abilities needed to satisfactorily perform the essential functions of the position satisfactorily and in accordance with the established performance expectations. The scope of the job may be modified with respect to the department, group, and on an individual assigned basis to a sometimes-specific testing group. Consideration of education, relevant training, and experience or a combination of all three may also result in further modification of th