Quality Control Associate - Bioassay

Vizen Life Sciences Pvt Ltd; Hyderabad; On-site; INR 600,000 - 900,000; Full time

Job summary

Vizen Life Sciences Pvt Ltd is seeking a bioassay specialist to perform testing and data release within defined timelines in a cGMP environment. You will prepare reagents, ensure equipment readiness, and document activities following GDP standards.

The role requires hands-on BA techniques such as ELISA, PCR, FACS, SPR and electrophoresis, with responsibilities including RCAs and team training. You will work in a tightly regulated lab, maintaining cleanliness and proper storage, while

Qualifications

• MSc/MTech/BTech in relevant bioscience field.
• Experience in Biologics/Biosimilar context is beneficial.
• Hands-on BA lab techniques and analytical methods required.

Responsibilities

• Perform bioassay testing for assigned samples and release data within defined timelines.
• Prepare reagents/buffers and ensure equipment availability for analysis.
• Document activities per GDP and participate in audits and investigations.
• Maintain lab cleanliness, proper sample storage, and equipment calibration/maintenance.
• Address instrument issues and conduct RCAs; train new team members.

Skills

Bioassay testing

Data release

Documentation

QMS compliance

Discrepancy closures

Root cause analysis

Training

Lab upkeep

Education

M.Sc./M.Tech./B.Tech in Microbiology/Biochemistry/Biotechnology

Tools

ELISA

PCR

FACS

SPR

Electrophoresis

Job description

Responsibilities

• Your responsibilities encompass Bioassay testing for assigned samples and releasing data within defined timelines, ensuring absence of executional errors against established procedures. You will be responsible for preparing required reagents and buffers in alignment with the testing plan and ensuring the availability of equipment for analysis.
• Your role involves documenting activities contemporaneously, adhering to Good Documentation Practices and compliance expectations, and conducting self-checks post-analysis to ensure accuracy.
• You will promptly inform the supervisor about risk actions, providing necessary data and analysis to support the investigation process. You will adhere to QMS (Quality Management systems) and closure timelines, actively participate in laboratory investigations and discrepancy closures, fulfilling defined roles in audits.
• Your responsibilities also include ensuring lab cleanliness, proper sample storage, chemical labeling, removal of expired material, usage of calibrated equipment, equipment calibration, maintenance, and qualification.
• You will address instrument-related issues and conduct root cause analyses (RCAs) for unknown problems, and play a crucial role in training new team members on analytical techniques.

Qualification & Experience

• An M.Sc., M.Tech. or B.Tech. in Microbiology, Biochemistry, or Biotechnology
• 4-8 years
• Basic understanding of the Biologics/Biosimilar industry, including processes, regulations, and trends.
• Hands-on experience in cell based bioassays, SPR technique, FACS techniques.
• Basic knowledge and hands-on exposure to cell culture techniques, specifically for working in Bioassay (BA) Labs.
• Hands-on experience in Biochemical analysis techniques, specifically Electrophoresis, Enzyme-Linked Immunosorbent Assay (ELISA), and Polymerase Chain Reaction (PCR), with a focus on Analytics.
• Working experience in a cGMP (Current Good Manufacturing Practice) environment, with a special emphasis on Good Documentation Practices (GDP).
• Basic knowledge in protein chemistry, including an understanding of protein structure, function, and relevant analytical techniques.
• Basic understanding about bioassay method validations.