Dohmen Life Science Services

Quality Assurance Associate

Job Locations US-CA-Emeryville
Job ID
2018-1954
# of Openings
1
Category
Quality Management Systems Services

Overview

THE POSITION

Position Title:    Quality Associate

Location:          Emeryville, CA

Reports to:       Director, Quality and Compliance

FLSA Status:    Exempt

 

OUR COMPANY

Since 1858, Dohmen has been driven by the desire to get safe and effective treatments and cures to the people that need them most. As entrepreneurs, we’ve looked for new and better ways of doing this year after year. Today, as Dohmen Life Science Services, we bring the industry’s most comprehensive service array to Medical Device, Biotech and Pharmaceutical entrepreneurs, helping them get farther faster and keeping them focused on innovations that improve lives.

 

Our behavior is guided by five simple values –

Caring: We are empathetic and respectful.  We ask “How can I help you?”

Committed: We are dedicated and persistent.  We ask “How can I make it happen?”

Creative: We are inventive and imaginative. We ask “How can I do it better?”

Collaborative: We are cooperative and share our knowledge. We ask “How can we achieve success?”

Courageous: We’re willing to risk failure over inaction. We ask “how can I challenge myself”

This perspective defines us. How we act, how we do business, how we work with our clients and how we work with each other. They are the essence of what makes us successful. They are what set us apart.

 

THE POSITION:

The most important aspect of this position is to take responsibility to support and assist in the development and management of quality systems at DLSS – Emeryville in addition to supporting the investigation and resolution to client audits and quality issues.

 

POSITION SUCCESS FACTORS:

  • Needs to be credible with both internal and external audiences and have unquestioned integrity.
  • Gives high priority to client satisfaction.
  • Appreciates the importance of this position toward the mentorship and guidance of staff.

 

 

Responsibilities

Responsibilities:

  • Provide support and assist in the development and management of quality systems at DLSS – Emeryville
  • Support activities to evaluate regulatory compliance
  • Help prepare inspection and audit responses and ensure tracking of corrective actions to closure
  • Ensure that post inspection/audit commitments are tracked and completed on time
  • Assist in the implementation of corrective/preventive action plans and quality system improvements (QNCR/CAPAs)
  • Support quarterly management review meetings by taking meeting minutes and assisting with creating data outputs for issue trending analysis.
  • Monitor training status to ensure on-time completion of quality management system training
  • Support the business continuity program, and act as a fire safety program coordinator
  • Assist in the development of standard operating procedures, work instructions, and resource documents as assigned.
  • Assist providing key performance indicator and quality metrics as assigned.
  • Administrative tasks, including updating, maintaining, and filing quality records.
  • Interact professionally with company management, internal departments, third parties and others relative to various quality initiatives
  • Act as project lead for continuous improvement opportunities
  • Interface with Account Executive Managers on key account initiatives

 

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:

The requirements listed below are representative of the knowledge, skill and/or ability required.

  • Bachelor degree with 0-2 years in pharmaceutical/biotech industry or quality assurance in GxP environment preferred.
  • Strong problem solving, risk assessment and impact analysis abilities.
  • Flexible and able to multi-task and prioritize competing demands/work load.
  • Excellent oral and written communication skills.
  • Experience with Customer Service (not require, but a plus)
  • Experience with managing projects (not require, but a plus)
  • Strong technical skills in MS Office (Outlook, Word, Excel, PowerPoint).
  • Experience with working directly or indirectly with end user of services

 

Personal Skills/Attributes/Qualifications

  • Strong problem solving, risk assessment and impact analysis abilities.
  • Flexible and able to multi-task and prioritize competing demands/work load.
  • Excellent oral and written communication skills.
  • Strong MS Office skills (Outlook, Word, Excel, PowerPoint).

 

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