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Senior Associate, Product Complaints (Quality Assurance)

Employer
Coherus BioSciences
Location
Redwood City, California
Start date
Apr 30, 2022

View more

Discipline
Marketing, Product Development/Management, Quality
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Biotech Bay

Job Details

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

The Senior Associate, Product Complaints operates with limited supervision to ensure compliance to Coherus’ 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 or work experience equivalent to a minimum 2+ years of experience in the pharmaceutical/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. 

Company

Coherus is focused on expanding patient access to important, cost-effective medicines and delivering significant savings to the U.S. healthcare system. Every member of the Coherus team is dedicated, motivated, and passionate about expanding patient access to lifesaving therapeutics. Our colleagues are experts in analytical and process sciences, deeply experienced in clinical development and regulatory affairs, and have proven commercial and marketing capabilities. Everyone at Coherus is committed to meeting the highest standards, inspiring our teammates, and achieving our goals.

Coherus was founded a decade ago to provide the highest quality biosimilar treatments to patients. We are proud to now be expanding our legacy—to build on our success with biosimilars and to focus our core strengths on immuno-oncology.

At Coherus, our employees are our most important asset. We have a dynamic and rewarding organizational culture that offers the opportunity to work with leading industry professionals who are dedicated to making a difference for patients. We are looking for individuals who see unlimited potential in themselves and are motivated by a continuous passion for breaking down barriers and expanding access to lifesaving therapeutics.

Coherus offers a competitive total rewards program comprised of various elements, including competitive base pay, short- and long-term incentives in the form of performance-based cash and equity, as well as health and wellness benefits that include

•    Healthcare: Coherus pays 90% of premiums for medical, dental, and vision coverage for our

     employees, their eligible spouses, dependents, and domestic partners.
•    Health Savings and Flexible Spending Accounts
•    Group Life, Disability, and Group Accident Insurance
•    401(k) with company match, and an Employee Stock Purchase Plan (ESPP)
•    Paid Time Off (PTO) 
•    Health & Wellness programs, including a Health Club Reimbursement and an Employee Assistance Program
 

Health & Wellness programs, including a Health Club Reimbursement and an Employee Assistance Program

In addition to providing attractive rewards packages, we encourage and support our employees to find the right balance of work and personal time. Coherus offers a variety of activities, perks, and holidays that encourage employees to have a healthy outlook, spend time outside of work with friends and family, and foster a productive and collaborative work environment. Our culture is one in which we challenge and support all our team members to do their best work.

For more information about Coherus, please check out: https://www.coherus.com/about-coherus/

Company info
Website
Phone
800-794-5434
Location
333 Twin Dolphin Dr, #600
Redwood City
CA
94065
United States

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