Quality Control Associate – Calibration (Biologics)
Location: Hyderabad, India
Department: Quality Control – Biologics
Employment Type: Full-Time
Experience Required: 6–9 Years in Quality Control within Manufacturing or Biopharmaceutical Environment
Job Overview
We are hiring a Quality Control Associate – Calibration to support biologics manufacturing operations in Hyderabad. This role is critical to maintaining laboratory accuracy, regulatory compliance, and product quality standards across raw materials, in-process samples, and finished biologic products.
The ideal candidate will have strong expertise in calibration management, analytical testing, regulatory compliance (FDA, ISO), and statistical quality analysis within a GMP-regulated manufacturing environment.
Key Responsibilities
Perform comprehensive quality control testing on raw materials, in-process samples, and finished biologic products in compliance with GMP standards.
Execute calibration, verification, and maintenance of laboratory instruments to ensure accuracy, reliability, and data integrity.
Analyze test data using statistical tools to identify trends, deviations, and potential quality risks.
Maintain detailed documentation and records in accordance with regulatory and internal quality management system (QMS) requirements.
Collaborate with production, engineering, and quality assurance teams to implement corrective and preventive actions (CAPA).
Ensure compliance with global regulatory standards, including FDA, ISO, and internal SOPs.
Participate in internal and external quality audits and contribute to continuous improvement initiatives.
Prepare structured quality control and calibration reports for management review.
Stay updated with emerging technologies, regulatory updates, and best practices in biologics quality control and laboratory calibration.
Educational Qualifications
Bachelor’s degree in Chemistry, Biology, Biotechnology, or a related scientific discipline
Experience Requirements
6–9 years of hands-on experience in Quality Control within pharmaceutical, biologics, or manufacturing environments
Proven experience in laboratory equipment calibration and analytical testing
Experience working in GMP-compliant facilities
Required Skills and Competencies
Technical Skills
Strong knowledge of quality control methodologies and statistical data analysis
Experience with calibration procedures for analytical and laboratory equipment
Familiarity with regulatory frameworks such as FDA guidelines and ISO standards
Proficiency in data management systems and Microsoft Office applications
Understanding of biologics manufacturing processes and their impact on product quality
Knowledge of CAPA, deviation management, and audit readiness practices
Behavioral Skills
High attention to detail with strong documentation discipline
Analytical thinking and structured problem-solving approach
Ability to work effectively in cross-functional teams
Strong communication skills, both written and verbal
Capability to perform in a fast-paced, regulated manufacturing environment
Preferred Qualifications
Professional certifications in Quality Control (e.g., ASQ certification)
Experience with laboratory information management systems (LIMS)
Exposure to biologics or biopharmaceutical production environments
Career Opportunity
This role offers an excellent opportunity for experienced quality control professionals to strengthen their expertise in biologics manufacturing, laboratory calibration systems, regulatory compliance, and quality assurance frameworks. It is well-suited for candidates seeking long-term growth in pharmaceutical quality control and GMP-regulated environments.
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