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Job Details

Sr. QA Associate

Company: SynteractHCR Deutschland GmbH
Location: Carlsbad, CA
Reference: 27203-DR
Closing Date: 26 Oct 17
Type: Full Time
Salary (£): On Application
Benefits: Excellent

Job Summary:

Overview The Senior QA associate contributes to Quality Assurance initiatives by assisting with development of SOPs and Work Instructions, and the management of standard operating procedures.  S/he ensures compliance with applicable regulatory requirements including setting of QA targets and ensuring compliance with SOP training and utilization.  The senior QA associate furthermore plans, conducts, and reports audits. This position can be based in Morrisville, NC or Carlsbad, CA.

Requirements:

Overview

The Senior QA associate contributes to Quality Assurance initiatives by assisting with development of SOPs and Work Instructions, and the management of standard operating procedures.  S/he ensures compliance with applicable regulatory requirements including setting of QA targets and ensuring compliance with SOP training and utilization.  The senior QA associate furthermore plans, conducts, and reports audits. This position can be based in Morrisville, NC or Carlsbad, CA.

 

Responsibilities

  • Performs the writing and revision of Standard Operating Procedures (SOPs) and Work Instructions.
  • Ensures training sessions are held on new/revised SOPs; ensures SOP training is documented and the training database is updated. 
  • Supports QA management in training of staff on new versions of SOPs.
  • Provides external SOP information to sponsors or 3rd party vendors.
  • Gather, analyze, and report QA metrics.
  • Provides oversight of QA and Risk Management plans for clinical trials.
  • Writes QA certificates for sponsors.
  • Performs the management of feedback questionnaires.
  • Assists with management of issue resolution and CAPAs.
  • Prepares for external audits conducted by clients, potential corporate partners, or regulatory agencies.  Contributes to audit responses. Performs follow up to ensure audit action items are closed.
  • Coordinates and conducts periodic internal audits.  Develops applicable documents and conducts audits related to training documentation, study files, TMF, System, or study-specific spot-check audits).
  • Assists with maintenance of QA Audit Plan for internal audits.
  • May provide day-to-day guidance and direction to lower level Quality Assurance personnel.
  • Monitors changes in federal regulations and notifies relevant departments of notable changes.
  • As needed, serves as back-up to other QA team members across job functions.

Qualifications

Academic & Professional Qualifications:

  • Bachelors degree in a related field of study and a minimum 5 years experience, or equivalent combination of studies and relevant work experience inclusive of quality management oversight.

Skills & Experience:

  • Sound knowledge of Quality Management Systems.
  • Advantageous: passed training in QA Systems according to ISO9001
  • ICH-GCP body of knowledge and the conduct of clinical trials.
  • Intermediate proficiency in Microsoft Word, Excel, and PowerPoint, Outlook.
  • Visio knowledge is an asset.
  • Effective verbal and writing skills; English + local language, if relevant.

     

 

What We Have to Offer

Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations

 

Who We Are

SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our “Shared Work – Shared Vision” philosophy we provide customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 15 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.

 

Our mission is to support the innovation and development of better therapies in healthcare. Our focus on patients’ safety and comfort helps us to establish ethical standards for everything we do.

 

SynteractHCR’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with SynteractHCR must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.


Apply for this job: Sr. QA Associate

Contact Information:

Address:  SynteractHCR Deutschland GmbH
Albrechtstrabe 14
80636 Munich
Germany
Tel:  +49 89 12 66 80 0
Fax:  +49 89 12 66 80 2444
Website:  Visit Our Web Site

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