Vacancies

Compliance Specialist

Job Title:Compliance Specialist
Reference:CS-2021
Location US ~ Garnet Valley, PA
Type: Full Time

Company Overview

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.

As a growing and successful business, we employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.

Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community, driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast.

 

The Role

  • Provide technical support for facilities, maintenance, and validation activities.
  • To create, revise and maintain facilities and engineering and technical documentation including but not limited to SOP’s, templates, work instructions, etc.
  • To create, revise, manage, and track facilities and engineering QMS items including but not limited to CC’s, CAPA’s, deviations, and audit observations.
  • To comply & adhere to Good Manufacturing Practice (GMP) standards.
  • To comply & adhere to Environmental, Health, & Safety (EHS) procedures and standards.

Main tasks and responsibilities will include:

  • Perform root cause analysis (RCA) to lead cross functional teams to investigate deviations and determine robust corrective actions, facilitate problem solving sessions, and support recurrent and complex deviations as Root Cause Champion.
  • Ensure timely completion of Facilities and Engineering (FE) departments Quality Event (QE) commitments. 
    • This includes writing, revising, or coordinating the efforts for change controls, standard operating procedures, audits, and training documentation.  Represent the FE department at the site change control review board meetings.  Prepare and track change controls to make improvements outside of deviations.
    • Initiate and assign FE department deviations using quality management system (QMS – i.e. Veeva).  Track, trend, and evaluate FE discrepancies and drive to eliminate root cause.  This includes tracking and trending using visual factory/metrics.  Maintain and track CAPA’s for the FE department.
  • Interact and coordinate with appropriate personnel including Manufacturing, Formulation, Analytical, QA, QC, Regulatory, Engineering, Validation, etc.  Communicate immediately with QA and Operations management for all FE discrepancies with potential to impact product quality or safety.
  • Develop internal audit schedule (including area/process to be audited) on a yearly basis and communicate the schedule to the site Quality organization.
  • Interact with external regulatory authorities as needed during routine and non-routine audits.  Act as lead support for FE gathering documents for audits.
  • To provide support and recommend continuous improvement initiatives utilizing lean manufacturing tools and/or other techniques.
  • Maintains compliance with applicable local, state, and federal regulations.
  • Performs other related duties as required and assigned.

Additional Tasks/responsibilities

  • Occasionally required to smell
  • Occasionally required to stand, and/or walk
  • Occasionally required to climb, balance, bend, stoop, kneel or crawl
  • Occasionally exposed to wet and/or humid conditions (non-weather)
  • Occasionally required to work near moving mechanical parts
  • Continually required to talk or listen
  • Frequently required to sit, type, and record information
  • Frequently required to utilize hand and finger dexterity
  • Frequently required to work independently as well as with others in a team environment

Job Demands

The job may involve the following:

  • Very high concentration of work
  • Quick shifts in priorities
  • Strict and tight deadlines
  • Having to juggle a range of tasks/issues simultaneously
  • Working in a hazardous environment with high requirement to follow safety procedures
  • Working outside normal working hours
  • Needing to respond to client demands

 

The Candidate

  • Required: Bachelor’s degree or other suitable degree relating to the position.  Bachelor of Science in Engineering or similar field preferred.
  • Required: 5-10 years performing similar duties as defined in this description.
  • Required: 3-5 years direct experience with quality management systems (QMS) which includes documents such as Deviations, CAPAs, Change Controls, and Investigations.  Veeva experience preferred.
  • Desired: 3-5 years of working in an FDA regulated GxP environment, an ISO 9002 environment, or other regulated environment with a defined quality system (e.g. – nuclear, food/beverage, etc.).  Pharmaceutical manufacturing experience preferred.
  • Desired: 3-5 years of experience in Root Cause Analysis (RCA) and/or Lean/SixSigma.
  • Required:  3-5 years of experience in Microsoft Word, Excel, PowerPoint, etc. 
  • Advanced working knowledge of Microsoft and/or other applications is preferred (i.e. Visio, Excel, Project, etc.)
  • Required: Experienced and capable of writing technical documentation such as SOP’s, templates, Work Instructions, Guidance Documents, etc.
  • Required:  Must be fluent in the English language, both written and verbally.

 

Company benefits

In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.

 

Our Commitment to Diversity & Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion.

We strive to create a diverse Quotient family by remaining committed to the development of our culture, equality, mindset, diversity & inclusion in the workplace.

As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. All applicants welcome.

If you have any questions or need some support with your application, we’d love to hear from you so contact our friendly team at careers@quotientsciences.com.