Cepheid QC Analyst Job Opening For Biotech & Biochem, Apply Online
Cepheid QC Analyst Job Opening For Biotech & Biochem, Apply Online. MSc Biotechnology. Biochemistry Quality Control Analyst I Vacancy. Interested and eligible applicants can check out all of the details on the same below
Name of the Post – Quality Control Analyst I
Location – Sriperumbudur Taluk, India
Job Family – Quality & Regulatory Affairs
Job ID – R1191302
JOB DESCRIPTION
POSITION SUMMARY–
- Reporting directly to the head of India Quality System and Regulatory Compliance (QSRC) manager, the Quality Control Analyst is responsible for managing the day-today activities quality control function at Cepheid India Private Ltd.
- Ensure compliance with quality control procedures as per MDR 2017, European regulations, ISO 13485, Cepheid corporate quality system requirements.
ESSENTIAL JOB RESPONSIBILITIES –
- Competent technical staff for supervision of the Testing/ analysis of diagnostic reagents & kits.
- Conducts routine and non-routine analysis of raw materials, in-process and finished formulations under the supervision and according to Standard Operating Procedures (SOPs).
- Compiles data for documentation of test procedures and prepares reports.
- Performs and calibration and maintenance of lab equipment.
- Reviews data obtained for compliance to specifications and reports abnormalities.
- Revises and updates SOPs.
- May perform special projects on analytical and instrument problem-solving.
- Ensure that lab cleanliness and safety standards are maintained.
- Train other analysts to perform laboratory procedures and assays.
- Perform inspections of incoming, in-process and finished products.
- Approves inspections of incoming, in-process and finished products.
- Participate in internal assessments and audits as required.
- Identify and troubleshoot product problems.
- Qualify test methods as part of new product development activities.
- Serve as a technical liaison between quality control and other departments
- Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses.
- Write or revise standard quality control operating procedures.
- Supply quality control data necessary for regulatory submissions.
- Perform validations or transfers of analytical methods in accordance with applicable policies or guidelines.
- Follow documentation procedure (filling out Data History Records (DHRs), reading and understanding instructions from Work Release (WR), Planned Deviation Report (PDR) or Non-Conformance Report (NCR). Read and follow Standard Operating Procedures (SOPs) and Manufacturing Work Instructions.
- Review records and documents for completeness and compliance with company policies and procedures.
- Monitors internal audit schedule, NC, CAPA for site
- Review production batch records, QC test results and release product.
All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities.
TRAINING RESPONSIBILITIES – (REQUIRED)
- Complete all assigned and required training satisfactorily and on time
MINIMUM REQUIREMENTS –
Education and Experience:
- Master’s degree in science (Biochemistry, Biotechnology, Pharmacy), medical or technical field and 4+ years experience with increasing responsibility in Quality Control area
- Experience within in-Vitro Diagnostics (IVD) is very beneficial and highly desirable
- A quality competent technical person approved as per D&C act if any
Knowledge and skills –
- Hands-on Experience in IVD product testing.
- Working Knowledge of current GxP regulations for Invitro Medical Devices and ISO 13485 QMS.
- Must be flexible to work off-shifts and weekends as per production schedule.
- Schedule orientated (able to consistently maintain schedules and meet timelines)
- Strong interpersonal skills, Effective organization and communication skills are essential.
- Good skills in the English language
- Knowledge of Microsoft Word and Excel
- Strong multi-tasking and attention to details skills.
PREFERRED REQUIREMENTS –
- Experience working with medical device quality systems in compliance with MDR and ISO 13485
- Able to interpret the quality problems and establish practical solutions within a dynamic business environment.
- Experience in leading continuous improvement efforts, in both quality systems and products.
- Knowledge of the process of establishing facility QMS certifications.
- Cross-functional experience with products and manufacturing processes to influence change at all levels within the organization Visio and Project knowledge desirable.
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