Vacancies

Quality Assurance Specialist

Job Title:Quality Assurance Specialist
Reference:QA-22-21
Location US ~ Boothwyn, 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 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

  • Perform data/document reviews, investigate/resolve non-conformances, and maintain change control systems.
  • To comply & adhere to GXP guidelines and regulations as required of this role.
  • Responsible for ensuring compliance through the Quality framework and follow procedures that govern the work performed in this role.
  • To comply & adhere to Good Manufacturing Practice (GMP) standards

Main tasks and responsibilities will include:

  • QA Specialist will review and approve Quality-related documents, including but not limited to: protocols; qualification, validation and stability reports; test results, including raw data; change control documentation; calibration certificates; and temperature charts.
  • Track and trend out-of-specification results, quality failure investigations, out of specification results investigation, deviations, change controls (equipment), complaints, and recalls or field alerts.
  • Write and review procedures and other controlled documents.
  • Periodic inspection of operations (including qualification and validation activities) to ensure compliance with written procedures, protocols, and regulatory requirements.
  • Create, issue, track, review, approve, and/or control labeling materials.
  • Inspect and release clinical and manufacturing supplies, manufactured products, raw materials, and/or chemicals

Additional Tasks/Responsibilities:

  •  Provide QA guidance on validation activities
  • Perform GMP audits
  • Provide training, as needed, and keep track of individual training needs, including follow-up with department supervisors
  • Play active role during regulatory and client inspection

Language Skills

  • Read and interpret documents such as safety rules, operating and maintenance instructions, and standard operating procedure manuals.
  • Write routine and technical reports and business correspondence and standard operating procedures manuals.

Mathematical Skills

  • Work with mathematical concepts such as probability and statistical inference.
  • Apply concepts such as fractions, percentages, ratios and proportions to practical solutions.

Reasoning Ability

  • Define problems, collect data, establish facts and draw valid conclusions.
  • Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Other skills, Abilities, or Qualifications

  • Experience with validations / qualifications (equipment/instrumentation/methods/process) in a cGMP environment.
  • Thorough knowledge and understanding of the current Good Manufacturing Practices (GMP), and International Conference on Harmonization (ICH) guidelines.
  • Experience working in manufacturing and/or laboratory environment.
  • Familiarity with the production process.
  • Successfully completes regulatory and job training requirements.
  • Computer skills:
  • Enter data into computer using software applications for data entry and word processing Microsoft Office, Software (Word, Access, Excel, Outlook, and PowerPoint).
  • Work and be proficient with e-mail systems
  • Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
  • Ability to perform under stress in cases of emergency, critical or hazardous situations.
  • Ability to work with others in a team environment.

Physical Demands

  • While performing the duties of this job, the employee is frequently required to stand and walk
  • The employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl.
  • The employee must occasionally lift and/or move up to 1O pounds.
  • Specific vision abilities required by this job include close vision, color vision and ability to adjust focus

 

The Candidate 

  • B.S. degree in a scientific field, e.g., chemistry, biology, or pharmacology
  • At least five (5) years related pharmaceutical industry experience desired.
  • M.S. degree in scientific field preferred.
  • Competent in the use of Microsoft Office packages including Word, Excel…etc.
  • Experience and knowledge of within GMP regulated environment.
  • Preferable experience of working in a manufacturing environment or equivalent experience in another role.

 

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.