Senior Quality Control Analyst - Pharmaceutical Testing

Placements24; Willows (CA); Hybrid; USD 39,000 - 55,000; Full time

Benefits offered by this job

Competitive salary

Medical aid

Generous annual leave

Professional development

Retirement fund

Stimulating work environment

Job summary

Placements24 represents a pharmaceutical client in Welkom, Free State, seeking a Senior Quality Control Analyst to join the QA team. The role focuses on analytical testing of raw materials, in-process samples, and finished products to ensure GLP, GMP, and regulatory compliance, while upholding the highest quality standards.

The ideal candidate holds a Bachelor's or Master's in Chemistry or a related field, with 4+ years' experience in pharmaceutical QC or analytical development, and is

Qualifications

• Minimum 4 years in pharmaceutical quality control or analytical development.
• Proficiency with HPLC and GC instrumentation.
• Strong knowledge of method validation and regulatory standards (ICH, USP, EP).
• Experience with OOS investigations and deviation management.
• Familiarity with GLP and GMP regulations in pharma.
• Excellent data analysis and clear written/verbal communication.

Responsibilities

• Perform analytical testing on materials and finished products using HPLC/GC/UV-Vis.
• Develop, validate, and transfer analytical methods per ICH standards.
• Interpret data and prepare accurate reports.
• Investigate OOS results and implement CAPAs.
• Maintain calibration and qualification of equipment.
• Ensure GLP and GMP compliance.
• Assist audits with documentation and explanations.
• Train and mentor junior QC analysts.
• Contribute to process improvements for efficiency and data integrity.

Skills

Analytical Chemistry

Quality Control

Data Analysis

Regulatory Knowledge

Attention to Detail

Communication Skills

Teamwork

Education

Bachelor's or Master's in Chemistry/Related Field

Tools

HPLC

GC

Spectrophotometry

Karl Fischer Titration

Job description

About the Role

Our client, a key player in the pharmaceutical industry, has an exciting opportunity for a Senior Quality Control Analyst to join their dedicated team in Welkom, Free State . This role is essential for ensuring the quality and integrity of pharmaceutical products through rigorous analytical testing. You will be responsible for performing a wide range of tests on raw materials, in-process samples, and finished products, ensuring compliance with all regulatory standards and internal specifications. The ideal candidate is meticulous, detail-oriented, and possesses a strong foundation in analytical chemistry and quality control principles. This position offers a chance to contribute to the safety and efficacy of medicines within a well-established organization located in the heart of the Free State. Join a team committed to upholding the highest standards of pharmaceutical quality and contributing to public health.

Key Responsibilities

• Perform analytical testing on raw materials, intermediates, and finished pharmaceutical products using various techniques (e.g., HPLC, GC, UV-Vis, Karl Fischer titration).
• Develop, validate, and transfer analytical methods according to ICH guidelines and pharmacopoeial standards.
• Interpret test results, analyze data, and prepare accurate and timely reports.
• Investigate out-of-specification (OOS) results and deviations, implementing corrective and preventive actions (CAPAs).
• Maintain laboratory equipment, ensuring proper calibration, qualification, and performance.
• Ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
• Participate in internal and external audits, providing necessary documentation and explanations.
• Manage laboratory inventory of chemicals, reagents, and consumables.
• Train and mentor junior QC analysts, providing technical guidance and support.
• Contribute to process improvement initiatives to enhance laboratory efficiency and data integrity.

Requirements

• Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Biochemistry, or a related scientific field.
• Minimum of 4 years of experience in pharmaceutical quality control or analytical development.
• Proficiency in operating and maintaining analytical instrumentation, particularly HPLC and GC.
• Strong understanding of method validation principles and regulatory requirements (ICH, USP, EP).
• Experience with OOS investigations and deviation management.
• Knowledge of GLP and GMP regulations in a pharmaceutical setting.
• Excellent data analysis and interpretation skills.
• Strong written and verbal communication skills, with the ability to document findings clearly and concisely.
• Meticulous attention to detail and a commitment to accuracy.
• Ability to work independently and as part of a team in a fast-paced laboratory environment.
• Experience with spectrophotometric and titrimetric methods is beneficial.
• Familiarity with stability testing programs is an advantage.

Benefits

• Our client offers a competitive salary package, reflective of the candidate's qualifications and experience, along with potential performance bonuses.
• Comprehensive medical aid, including hospital cover and preventative care, is provided.
• A generous annual leave allowance and paid sick leave contribute to work-life balance.
• Opportunities for professional development, including workshops and advanced training courses, are available.
• The company also provides a retirement fund with employer contributions.
• Employees enjoy a stimulating work environment in Welkom, working with advanced analytical technologies and contributing to the development of essential medicines.
• Our client is dedicated to fostering a culture of continuous improvement and offers pathways for career progression within the quality assurance and control functions.