Senior Quality Assurance Specialist

5 days ago


Fall River, Massachusetts, United States Cipla USA Full time

Job Title: Senior Quality Assurance Specialist

Job Summary:

Cipla USA is seeking a highly skilled Senior Quality Assurance Specialist to join our team in Fall River, MA. As a Senior Quality Assurance Specialist, you will be responsible for ensuring the compliance of protocols and reports, monitoring Good Laboratory Practices, and verifying standard operating procedures.

Key Responsibilities:

  1. Protocol and Report Compliance: Confirm and ensure the compliance of protocols and reports of method validations, verifications, and comparison reports.
  2. Good Laboratory Practices: Monitor and ensure current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation.
  3. Standard Operating Procedures: Verify the standard operating procedures (SOPs) and test procedures.
  4. Document Management: Maintain all incoming documents with proper tracking, recording, storage, and archival.
  5. Regulatory Compliance: Coordinate with Regulatory Affairs and Analytical Laboratory Teams to arrange required documents for timely submission.
  6. Quality Control: Evaluate and confirm compliance related to raw materials, in-process, and finished product analytical documents.
  7. Internal Audits: Conduct random internal audits in the analytical lab and ensure compliance.
  8. Pharmacopoeia Changes: Assess and implement Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes are in effect.

Requirements:

  1. Education: Possess a bachelor's degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution. Master's degree in the above and/or related fields of study preferred.
  2. Experience: A minimum of eight (8) years of relevant work experience in a pharmaceutical manufacturing setting within the Quality function.
  3. Skills: Proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.
  4. Knowledge: Strong knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good Distribution Practices (GDP), etc.

Working Conditions:

  1. Work Environment: This role works in a cGMP laboratory or manufacturing environment, where personal protective equipment (PPEs) is required.
  2. Work Schedule: Must be willing to work any assigned shift ranging from first, second, or third shift. Work schedule may be Monday to Friday, Tuesday to Saturday, or some combination thereof based on business needs.
  3. Relocation: Relocation negotiable.
  4. Remote Work: No remote work available.

About Cipla USA:

Cipla USA is a leading global pharmaceutical company, dedicated to high-quality, branded and generic medicines. We are trusted by healthcare professionals and patients across geographies. Our focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.



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