Quality
Control Analyst @ Cepheid Inc is an American molecular diagnostics company
About Us
At Cepheid,
we are passionate about improving healthcare through faster, more accurate
diagnostic tests. With our GeneXpert® System, we’ve taken the most
sophisticated molecular technology and packaged it into an automated,
easy-to-use format that has quickly become the platform of choice worldwide.
From the largest laboratories to small physician offices, our game-changing
solution delivers critical answers when clinicians and patients need them most.
Through strong molecular biology capabilities and ongoing product innovation,
we are focused on developing tests for healthcare-associated infections, sexual
health, critical infectious disease, virology, and oncology applications. Come
join our vision for a better way and help make life better for us all! For more
details, visit us at www.cepheid.com or follow us on Twitter (@CepheidNews).
Description
Job Title:
Quality Control Analyst
Job Location:
India-Karnataka-Bengaluru
GCRF Job
Level: P1
GCRF Job
Family: Quality and Regulatory Affairs
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 of quality control procedures as per MDR 2017, European regulations,
21 CFR 820, ISO 13485, Cepheid corporate quality system requirements.
ESSENTIAL JOB
RESPONSIBILITIES:
• Conducts
routine and non-routine analysis of raw materials, in-process and finished
formulations under 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.
• Act as
approved competent person for Quality Control as per MDR 2017.
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:
• Complete
all assigned and required training satisfactorily and on time
Qualifications
MINIMUM
REQUIREMENTS:
Education and
Experience:
• Master’s
degree in science (Biochemistry, Biotechnology, Pharmacy), medical or technical
field and 2+ years’ experience with increasing responsibility in Quality
Control area
• Experience
with in Vitro Diagnostics (IVD) is very beneficial and highly desirable
• Quality
competent technical person approved as per D&C act if any
Knowledge and
skills:
- Hands on
Experience on 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 maintains schedules and meet timelines)
- Strong
interpersonal skills, Effective organization and Communication skills are
essential.
- Good skills
in 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 quality problem 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
Danaher
Corporation Overview
Danaher is a
global science & technology innovator committed to helping our customers
solve complex challenges and improve quality of life worldwide.
Our world class
brands are leaders in some of the most demanding and attractive industries,
including life sciences, medical diagnostics, environmental and applied
solutions.
Our globally diverse team of 71,000 associates is united by a common
culture and operating system, the Danaher Business System, which serves as our
competitive advantage. We generated $19.9B in revenue last year. We are ranked
#162 on the Fortune 500 and our stock has outperformed the S&P 500 by more
than 5,200% over 25 years.
At Danaher,
you can build a career in a way no other company can duplicate. Our brands
allow us to offer dynamic careers across multiple industries.
We're innovative,
fast-paced, results-oriented, and we win. We need talented people to keep
winning. Here you'll learn how DBS is used to shape strategy, focus execution,
align our people, and create value for customers and shareholders. Come join
our winning team.
Danaher is
committed to competitive compensation that typically has key components
including base salary, variable annual incentive compensation based on personal
and company performance, and long-term incentive.
TO APPLY CLICK HERE
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