QA Specialist

Quotient Sciences

Quotient Sciences

Software Engineering, Quality Assurance
Boothwyn, PA, USA
Posted on Friday, June 28, 2024

QA Specialist

Boothwyn, PA, USA Req #214
25 June 2024
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 that’s focused on innovation and are 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

  • Ensuring operations are compliant with internal procedures and regulatory requirements
  • Supporting the provision and development off efficient and effective Quality Management System
  • Work effectively with colleagues across all functional areas to achieve objectives while maintaining good working relationships.
  • Give information in a clear, concise and timely manner and often use negotiation and consultation skills to resolve complex issues.
  • Coordinating the review of documentation in support of manufacturing activities and the QA project teams.
  • 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.

Main Tasks and Responsibilities

  • Review and provide feedback on equipment qualifications, process validation, analytical method validations, stability study documents, risk assessments, product specifications, master batch records, and SOPs.
  • Participate in tech transfer activities to support customer registration, scale up, validation and commercialization readiness.
  • Provide QA support and oversight to the production of registration batches and commercial product material to ensure that product is manufactured in accordance with specifications, our customer’s market authorizations and GMP requirements. Conducts floor audits and periodic checks of in process documentation and log books for compliance.
  • Provide guidance to manufacturing and laboratory personnel to proactively ensure GMP compliance.
  • Review executed batch records, analytical test results and raw data, and provide input to QA Specialists for their product release. As required, work to resolve identified issues to support timely release of product that conforms to specifications.
  • Participate in investigations related to deviations, out-of-specifications or atypical results, and customer complaints. Identify and implement corrective and preventive actions that mitigate potential for issue recurrence.
  • Communicate quality-related information and data to key stakeholders within and outside of QA.
  • Participate in the planning and execution of customer audits. As required, support the compilation of responses to customer audit findings to assure they are submitted to customers on time.
  • Participate in regulatory inspections to ensure successful results.
  • Supporting the collation of Quality metrics
  • Participation in the change control process to ensure changes to processes and systems are managed appropriately to maintain GCP Compliance
  • Development and continual improvement of the company quality system as required
  • Provision of Quality training in line with Quotient defined standard
  • Provide work product that meets the highest quality standards by ensuring work is accurate and delivered in accordance with established timelines. Keep the QA Specialists informed on the status of customer-specific activities.

The Candidate

  • Associate degree in a scientific field, or equivalent experience
  • Minimum three (3) years’ related experience in QA or QC in life sciences
  • Good understanding of CGMP requirements
  • Good organization and time management skills
  • Effective written and oral communication skills
  • Good interpersonal skills with a special focus on customer satisfaction.
  • Experience working with Good Manufacturing Practices (GMP) preferable.

Application Requirements

When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.

Our Commitment to Diversity, Equity and Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.

Other details

  • Pay Type Salary