QA Analyst I

Cipla; Fall River (MA); On-site; USD 50,000 - 90,000; Full time

Job summary

An established industry player is seeking a dedicated QA Analyst I to ensure product quality throughout the manufacturing process. This role involves performing in-process testing, conducting equipment checks, and maintaining compliance with established SOPs. As a key member of the quality team, you will contribute to the integrity of pharmaceutical products while working in a collaborative environment. If you have a keen eye for detail and a passion for quality assurance, this position offers a rewarding opportunity to make an impact in the pharmaceutical sector.

Qualifications

• Minimum of three years in quality assurance in a GMP environment.
• Advanced training in pharmaceutical manufacturing preferred.

Responsibilities

• Perform in-process testing and inspections as per batch records.
• Monitor environmental conditions and maintain quality records.
• Identify and report non-conformances to management.

Skills

Attention to Detail

Interpersonal Skills

Communication Skills

Knowledge of cGMP

Organizational Skills

Multitasking

Education

High School Diploma

Vocational Training in Pharmaceutical Manufacturing

Tools

Microsoft Office

SAP

Job description

Job Title: QA Analyst I - On-the-floor Inspector

FLSA Classification: Full-Time, Exempt Professional

Work Location: Fall River, MA

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

Reports To: Quality Assurance Manager

PURPOSE

The purpose of the QA Analyst position is to monitor and ensure product quality is maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs).

SCOPE

The scope 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.

JOB DESCRIPTION

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 may be matrixed to other functional leaders within the Quality or other departments.

Essential Job Duties:

• 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 follow 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 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

• Minimum high school diploma.
• 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) years’ experience in 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.

OTHER JOB INFORMATION

• 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.

About InvaGen Pharmaceuticals, a Cipla subsidiary: InvaGen Pharmaceuticals, Inc. is engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with a focus on a range of therapeutic areas. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York.

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.