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Quality Control Analyst

  • Accord Healthcare

    • On-site
    • Raleigh, NC

1–1 of 1 job

Quality Control Analyst

  • Accord Healthcare

  • Raleigh, NC 27617
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On-site

$28,000 - 29,000/ Year

Pharmaceutical

R&D

  • Posted on:
  • No. of Vacancies:

Job Description

Summary

Accord Healthcare is an award-winning pharmaceutical company driven to thinking differently so that more patients around the world have access to the essential and affordable medicines that they need. With operations in over 85 countries worldwide, and a pan-European footprint of more than 45 countries, Accord Healthcare develops, manufactures and distributes affordable medicines, and has one of the most active launch programmes in the European pharmaceutical sector. Life at Accord Healthcare is fast-paced and agile. We drive for results and are committed to delivering the highest possible standards because we understand that everything we do has an impact for our customers and for the patients that receive our medicines. We always strive to make it better by challenging ourselves to think differently and to deliver more every day. Whether it is product development, improving our systems and operations or building patient-focused added value services, we realise that each innovation could improve the lives of the patients who receive our medication. Living our purpose and achieving our goals means we can deliver more vital, affordable medicines to national health systems and the patients who need them most. At Accord we recognise that developing the skills and capabilities of our people is essential to the achievement of our organisation goals and we support each and every employee in doing so.




Responsibilities

1. Routine Testing & Analysis

  • Perform qualitative and quantitative analysis of raw materials, in-process samples, and finished products.
  • Conduct testing using instruments such as HPLC, GC, UV–Vis, FTIR, Dissolution, and Wet Chemistry techniques.
  • Ensure all test results comply with approved specifications, SOPs, and regulatory requirements.

2. Documentation & Data Integrity

  • Record all observations and results accurately in lab notebooks, worksheets, or LIMS.
  • Prepare and review Certificates of Analysis (COA) and testing reports.
  • Follow ALCOA+ data integrity principles.

3. GMP & Regulatory Compliance

  • Adhere to cGMP, GLP, and company SOPs for all laboratory operations.
  • Participate in internal and external audits (USFDA, MHRA, EMA, WHO).
  • Ensure compliance with calibration, qualification, and maintenance schedules.

4. Handling Laboratory Equipment

  • Operate, calibrate, and troubleshoot analytical instruments.
  • Maintain equipment logs and ensure proper instrument performance.
  • Support IQ/OQ/PQ activities if required.

5. Stability & Retention Sample Management

  • Conduct stability studies in accordance with ICH guidelines.
  • Manage retention samples and maintain proper storage conditions.
  • Monitor stability chambers and document results.

6. Deviation, OOS & OOT Investigations

  • Assist in root cause analysis for OOS (Out-of-Specification) and OOT (Out-of-Trend) results.
  • Document deviations and support CAPA implementation.
  • Ensure timely escalation and closure of investigations.

7. Method Validation & Transfer (If applicable)

  • Support method development, method validation, and method verification.
  • Participate in analytical method transfer between facilities


Qualifications

B.Pharm / M.Pharm (Preferred for QC in pharma manufacturing)

B.Sc / M..Sc in Chemistry, Pharmaceutical Chemistry, Microbiology, or Biotechnology

Diploma in Pharmacy (for some entry-level QC technician roles)

Education

Degree

Bachelor Degree

Specialization

CHEMISTRY
Experience:

3-5 yrs

  • Skills:
  • Hands-on laboratory testing: HPLC, GC, UV-Vis, FTIR, Dissolution, Wet Chemistry techniques. Analyti
  • Job Type:
  • Full-time
  • Shift Type:
  • 8 hour shift

Compensation

  • Benefits:
  • 401K Match
  • Additional:
  • Base Salary

Job ID:

CGXP_25_0605

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