Qa Analyst I

3+ years

Not Disclosed

Remote, USA

10 Jan. 2, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: QA Analyst I - On-the-floor Inspector
Location: Fall River, Massachusetts
Posting Date: December 25, 2024
Job ID: 86408
FLSA Classification: Full-Time, Exempt Professional

About Cipla:

Cipla is a global leader in the pharmaceutical industry, committed to providing high-quality, affordable branded and generic medicines. Our mission, "None shall be denied," drives us to improve healthcare across the globe, with a focus on making a significant impact in markets such as India, South Africa, the U.S., and other emerging economies. We are deeply invested in providing life-changing medications and are seeking passionate professionals to join our team.

The Role:

We are looking for a QA Analyst I - On-the-floor Inspector to join our Quality Assurance team at InvaGen Pharmaceuticals, a Cipla subsidiary in Fall River, MA. This position is responsible for ensuring product quality is maintained throughout all phases of the manufacturing process, following established specifications and Standard Operating Procedures (SOPs).

Key Responsibilities:

Perform in-process testing such as weight, thickness, hardness, disintegration, friability, etc., following manufacturing batch record instructions.
Conduct room and equipment checks per written procedures.
Execute AQL sampling and inspections as required.
Inspect in-process and finished product samples for the QC Lab and provide necessary documentation.
Maintain records of standard weights and perform daily verification of balances.
Ensure isolation of rejected materials and maintain batch record accountability.
Monitor facility and product environmental conditions, reviewing records such as temperature and humidity data, calibration, PM records, and pest control.
Review online batch records for completeness and accuracy before proceeding with the next manufacturing step.
Verify equipment functionality during the batch process.
Participate in customer complaint investigations and report findings.
Identify and report non-conformances and discrepancies.
Contribute to other duties and participate in project work as assigned by management.

Qualifications:

Required:

High school diploma.
Minimum of 3 years of experience in a quality assurance role in a GMP pharmaceutical environment.
Familiarity with MDI or parenterals is preferred.

Preferred:

Advanced vocational training or education in pharmaceutical manufacturing, industrial management, or related fields.

Skills & Abilities:

Proficient in Microsoft Office tools and business applications like SAP.
Strong interpersonal and teamwork skills.
Knowledge of cGMP practices.
High attention to detail and ability to multitask under strict deadlines.
Strong organization, communication (written, verbal, presentation) skills.
Self-starter with a proactive approach to training and learning.

Additional Information:

No relocation available.
No remote work available.
No employment sponsorship available.

About InvaGen Pharmaceuticals (Cipla subsidiary):

InvaGen Pharmaceuticals, a Cipla subsidiary, specializes in developing, manufacturing, marketing, and distributing generic prescription medicines across various therapeutic areas, including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. Founded in 2003, InvaGen operates as a part of Cipla, strengthening its global focus.

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Qa Analyst I

Job Description

About Cipla:

The Role:

Qualifications:

Additional Information:

About InvaGen Pharmaceuticals (Cipla subsidiary):

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