Senior QA Associate, Clinical
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 Sr. QA Associate will support the QA Specialists on projects providing early phase pharmaceutical formulation, development, and clinical trial manufacturing support to our clients. The majority of projects will involve oral solid dosage pharmaceutical products in various stages of development, from pre-formulation through registration. The Sr. QA Associate will support the development and implementation of an efficient and effective quality management system, maintain open and timely communication across the team, and visibly demonstrate the behaviors necessary to maintain compliant GMP practices and advance the quality culture.
Main tasks and responsibilities will include:
- Support the QA Specialists that serve as project teams for early phase pharmaceutical formulation, development, and manufacturing in support of clinical trials by:
- Actively participate in project meetings.
- Reviewing and providing feedback on pharmaceutical development reports, equipment qualifications, analytical method qualifications, process verifications, stability study documents, risk assessments, product specifications, and SOPs.
- Distributing fully reviewed and executed quality documents and records to customers in accordance with company procedures.
- Perform supplier quality assessments and, as necessary, participate in supplier audits to ensure suppliers and subcontractors to be used for the clinical product are properly qualified in accordance with the supplier management program.
- Provide QA support and oversight to the production of clinical trial material to ensure that product is manufactured in accordance with specifications and GMP requirements.
- Perform GMP inspection and release of manufacturing equipment and rooms, including potent suites.
- Review and release raw materials and components to be used in the manufacture of clinical trial material.
- Generate, review and issue labels for clinical trial manufacturing/formulation development.
- 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 related to the clinical trial product. Implement corrective and preventive actions that mitigate potential for issue recurrence.
- Communicate quality-related information and provide input to team decisions.
- For products moving from early to late stage, participate in tech transfer activities to support customer registration, scale up, validation and commercialization readiness.
- Participate in the planning and execution of customer audits. As required, lead efforts to ensure responses to customer audit findings are complete and timely.
- Participate in regulatory inspections to ensure successful results.
- 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 project-specific activities.
- Perform other duties as assigned.
The job may involve the following:
- Very high concentration of work
- 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
- 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 10 pounds.
- Specific vision abilities required by this job include close vision, color vision and ability to adjust focus.
- Must be able to qualify for respiratory protective equipment use.
- Associate degree in a scientific field, or equivalent experience
- Minimum five (5) years’ related experience in QA or QC in life sciences
- Strong understanding of CGMP requirements, and pharmaceutical quality systems
- Experience in GMP analytical testing and knowledge of HPLC preferred
- Experience in solid dose manufacturing desirable.
- Good organization and time management skills
- Good written and oral communication skills
- Ability to work independently and effectively across multiple cultures and with cross-functional teams
- Good interpersonal skills with a special focus on customer satisfaction.
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.