Quality Assurance Associate - Concord, CA | Biospace
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Quality Assurance Associate

Cerus Corporation

Location:
Concord, CA
Posted Date:
12/1/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
QA, Quality, Quality Assurance,

Job Description

Primarily responsible for assuring compliance with regulatory requirements (FDA, MDD) and ISO standards.  Will provide GLP, GMP, and ISO 13485 compliance support as necessary.

Primary Responsibilities:

•   Identify compliance weaknesses and ensure the implementation of workable solutions.
•   Write/revise/review SOPs/INSs as necessary
•   Provide support for product complaint management including complaint registration, investigation, trending and follow-up with customers.
•   Audit reports and raw data for compliance with protocols, SOPs and regulations
•   Perform internal and supplier quality audits and facilitate corrective actions.
•   Review and provide guidance for various non-conformance situations and investigations activities, evaluate root cause and corrective actions, and ensure documentation is complete, accurate, and closed in a timely manner.
•   Communicate compliance requirements at all levels.
•   Provide training and guidance in the areas of government regulations to effected employees.
•   Perform other related duties as required.

Requirements

•   Bachelor’s degree or equivalent in a scientific discipline with a minimum of 3 years’ experience in the pharmaceutical or medical device industry or Master’s Degree with a minimum of 2 years’ experience.
•   Minimum 1 year of experience in regulated operations.
•   Understanding of the FDA QSR regulations, Medical Device Directive, ICH Q7, and the ISO 13485 standard.
•   Experience with product complaint handling, including investigation and documentation.
•   Ability to exercise independent judgment.
•   Strong data review and technical writing skills.
•   Experience with product complaint handling, including investigation and documentation.
•   High-level understanding of scientific approach and analytical thinking of others.
•   Strong communication skills (encompasses verbal, written, interpersonal, listening).
•   Ability to influence others.
•   High level of attention to detail and accuracy; very observant in order to audit properly.
•   Flexible; ability to adapt to changing priorities.
•   Excellent time management skills (schedules, timelines, task prioritization).