Quality Assurance Analyst

Cipla; Fall River (MA); On-site; USD 62,000 - 76,000; Full time

Job summary

Cipla seeks a Quality Assurance Analyst for its Fall River facility. This full-time role requires ensuring product quality throughout manufacturing processes by conducting tests and inspections. Candidates should have vocational training in pharmaceutical manufacturing and at least three years of QA experience. Strong attention to detail and cGMP knowledge are essential.

Qualifications

• Advanced vocational training or education in pharmaceutical manufacturing preferred.
• Minimum of three (3) years' experience in a quality assurance in GMP pharmaceutical manufacturing.

Responsibilities

• Perform in-process testing per manufacturing batch record instructions.
• Conduct room and equipment checks prior to each stage of manufacturing.
• Ensure proper isolation of rejected material and accountability in batch records.

Skills

Attention to detail

Interpersonal skills

Organizational skills

Communication skills

cGMP knowledge

Education

Vocational training in pharmaceutical manufacturing or related field

Tools

Microsoft Office

SAP

Job description

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FLSA Classification: Full-Time, Exempt Professional

Work Location: Fall River, MA

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

Reports To: Quality Assurance Manager

Salary Range: $62,400 - $75,400 (DOE)

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

The Quality Assurance (QA) Analyst position is an individual contributor role and a member of the InvaGen Pharmaceuticals Quality Team. The position reports to the Quality Assurance Manager and maybe matrixed to other functional leaders within the Quality or other departments.

The essential and typically expected job duties for this position include but are not limited to the following:

• Perform in-process testing (e.g. weight, thickness, hardness, disintegration, friability, etc.) as per manufacturing batch record instructions.
• Conduct room and equipment checks (where applicable) prior to each stage of manufacturing by following detailed written procedures.
• Execute acceptable quality limit (AQL) sampling and inspections as required.
• 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 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 functionality of all the equipment and associated controls during the batch run.
• Perform applicable testing and prepare reports for customer complaints.
• Identify and report any non-conformances and/or discrepancies to management if applicable.
• Complete other duties or participate in project work as assigned by management.

EDUCATION AND EXPERIENCE QUALIFICATIONS

• Advanced vocational training or education in pharmaceutical manufacturing, industrial management or related field of study from an accredited college/university.is preferred.
• Minimum of three (3) yearsâ experience in a quality assurance in a GMP pharmaceutical manufacturing operation and work environment.
• Experience in MDI or parentals preferred.

KNOWLEDGE, SKILLS, AND ABILITIES

• 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 have strong attention-to-detail.
• Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
• Must have strong organization and communication skills (written, verbal, and presentation).
• Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.

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 Indiaâs 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, Ciplaâs focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

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.