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QA Associate - United States  

Company managed [?] Still accepting applications

Posted on : 02 May 2017

Project Description

Tracking Code
1511-050
Job Description

Bioclinica, Inc. is looking for intelligent, creative and dedicated professionals to join our growing team. We are a company that values technical excellence, teamwork and a commitment to success. We employ cutting edge technology to provide our customers with industry leading solutions and are currently seeking to fill the position of QA Associate to work out of our Newark, CA office.

Primary Responsibilities

Facilitates the management of the electronic document management system (“EDMS”) by:

  • Managing the departments, roles, and training courses setup and maintenance
  • Ensuring the proper routing of documents for approval and training
  • Providing training and guidance to staff regarding the use of the system
  • Ensuring continuity among corporate and divisional work teams by documenting and communicating actions, irregularities and continuing needs

Facilitates the identification and development of Standard Operating Procedures (“SOP”) or Work Instructions (“WI”) by:

  • Managing the writing, revising, reviewing and approving of all SOPs and WIs
  • Ensuring the proper management of SOP and WI documentation and tracking
  • Providing training and guidance to staff regarding compliance and interpretation of SOPs and WIs

Assists with the management of various other quality assurance initiatives and programs by:

  • Participating in the development and maintenance of all quality systems and process improvements
  • Leading and investigating quality issues and implementing corrective actions; identifying departmental strengths and weaknesses
  • Supporting the development and implementation of proper document management and change control processes
  • Assisting with the scheduling, planning, conducting and reporting of audits

Maintains Quality Service and Departmental Standards by

  • Reading, understanding and adhering to organizational Standard Operating Procedures
  • Establishing and enforcing departmental standards

Secondary Responsibilities

Contributes to team effort by

  • Exploring new opportunities to add value to organization and departmental processes
  • Helping others to accomplish results
  • Performing other duties as assigned

Maintains Professional and Technical Knowledge by

  • Attending and participating in applicable company sponsored training
  • Attending educational workshops and reviewing professional publications
  • Benchmarking state-of-the-art practices
  • Participating in professional societies
  • Keeping informed of changes in the regulatory environment and/or regulatory requirements

Working conditions:

Travel: 0-15%

Lifting: 0-25lbs

Other: Computer work for long periods of time

Required Skills

Qualifications:

Education:

  • Bachelor’s degree required, preferably in life sciences. Advanced degree preferred

Additional skill set:

  • Strong interpersonal, both verbal and written
  • Strong organizational and leadership skills
  • Goal oriented
  • Ability to maintain professional and positive attitude
Required Experience

Experience:

  • 3+ years experience in creating and maintaining SOPs preferred
  • 3+ years current experience in a Regulatory or Quality Assurance role within the pharmaceutical industry
  • Demonstrated above average written communication skills in the English language
  • Proven ability to work with and direct teams to accomplish goals
  • Must be familiar with US and EU regulations and guidance
Job Location
Newark, California, United States
Position Type
Full-Time/Regular