Senior Associate, Product Complaints (Quality Assurance)

Location
Redwood City, California
Posted
Jun 29, 2022
Ref
4195260
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Title:                                    Senior Associate, Product Complaints (Quality Assurance)
Reports To:                         Associate Director, Complaints, Quality Assurance
Location:                             Redwood City, California
Classification:                    Exempt 
 
Overview:

The Senior Associate, Product Complaints operates with limited supervision to ensure compliance to Coherus’s Global Product Complaint Management Process. This position receives, logs, analyzes and reconciles Coherus product quality complaints and is the subject matter expert for day to day processing issues. Utilizes sound judgement to develop and recommend solutions to a variety of moderately complex quality events and issues related to the complaint management process. Investigates process related failures using the deviation system and implements CAPAs when appropriate. Conducts QA duties in compliance to global SOPs, cGMP’s and in accordance with company policies, procedures, and federal regulations

Principal Responsibilities

Note:  The following is meant to be representative but not necessarily all inclusive of the duties and responsibilities for this position title:

  • Ensures complaints are processed in compliance with Coherus ’s Global Product Complaint program activities as required by SOPs as well as cGMP regulations.
  • Performs and oversees the daily Product Complaint processing activities including: complaint initiation, due diligence, investigation assignment, investigation closure, complaint closure, and the identification of potential Quality risks and/or trends for escalation to management.
  • Initiates and manages complaint investigations related to the Global Product Complaint process as required and in collaboration with local/global Quality staff.
  • Supports internal and regulatory body inspections, as needed.

Qualifications

  • Bachelors Degree in Engineering, Biotechnology or other scientific or project management field.  Or work experience equivalent to a minimum 2+ years of experience in the pharmaceutical or biological industry.
  • 2+ years of demonstrated direct QA experience in a cGMP environment.
  • Experience with product quality complaint management systems with medical device experience preferred.
  • Strong Knowledge of FDA guidelines and regulations regarding cGMPs.
  • Exercise sound and independent judgment and decision making.
  • Excellent interpersonal and communication skills.
  • Exceptional attention to detail.
  • Strong computer skills, including EDMS systems and all MS Office applications.
  • Exceptional ability to partner cross-functionally with different teams and projects.
  • Strong initiative and ability to assume significant project management skills.
  • Ability to work in a fast-paced, dynamic environment.

Language Skills:

Ability to write reports, presentations and email correspondence.  Must effectively present information and respond to correspondence from managers, program management and other groups both internal and external as required.

As an employee of Coherus, you will actively contribute to the development of potential new products. We provide opportunities for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs and stock options reflect Coherus' high regard for our employees.

Beginning July 19, 2021, Coherus BioSciences requires all new hires to be fully vaccinated against COVID-19 as of their start date.  This requirement is a condition of employment at Coherus BioSciences, and it applies regardless of whether the position is located at a Coherus BioSciences facility or is fully remote.  If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.