Cepheid QC Analyst For Mol Bio, Microbiology & Biochem, Apply Online
Cepheid QC Analyst For Mol Bio, Microbiology & Biochem, Apply Online. MSc Biochemistry, Molecular Biology, Microbiology 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 – Bengaluru, Karnataka, India
Job Family – Quality & Regulatory Affairs
Job ID – R1215507
JOB DESCRIPTION
POSITION SUMMARY–
- This position is part of the Quality Organization and will be in Bengaluru, India. Reporting directly to the Quality Control lead, 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, and Cepheid corporate quality system requirements.
ESSENTIAL JOB RESPONSIBILITIES –
- Conducts routine and non-routine analysis of raw materials, in-process and finished formulations under the supervision and according to Standard Operating Procedures (SOPs).
- Competent technical staff for supervision of the Testing/ analysis of diagnostic reagents & kits.
- Perform inspections of incoming, in-process and finished products.
- Compiles data for documentation of test procedures and prepares reports.
- Performs calibration and maintenance of lab equipment as per requirements.
- May perform special projects on analytical and instrument problem-solving.
- Ensure that lab cleanliness and safety standards are maintained.
- 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.
- 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.
- Support for internal audit schedule, NC, CAPA for site.
- Review production batch records, QC test results and release product.
All listed tasks and responsibilities are deemed essential functions to this position; however, business conditions may require reasonable accommodations for additional tasks and responsibilities.
TRAINING RESPONSIBILITIES – (REQUIRED)
- Complete all assigned and required training satisfactorily and on time
MINIMUM REQUIREMENTS –
Education and Experience:
- Master’s degree in Biochemistry, Molecular Biology, Microbiology or related discipline and a minimum of 3+ years related Quality Control experience.
- 2+ years of experience with in Vitro Diagnostics (IVD) is a mandate
- Experience with 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 detail skills.
PREFERRED REQUIREMENTS –
- Experience working with medical device quality systems in compliance with MDR and ISO 13485
- Able to interpret 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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