US ~ Boothwyn, PA
QA Associate - Commercial
Our growing and successful business comprises of over 800 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specialising in delivering innovative solutions that integrate formulation development, real time GMP manufacturing and clinical testing We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
The QA Associate will support the QA Specialists on the contract manufacturing and testing of registration and commercial products, which primarily involve oral solid dosage pharmaceuticals. The QA Associate will support the technology transfer for commercial manufacturing and provide QA oversight of the manufacturing and testing of products. They will ensure the implementation and maintenance 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:
- 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.
- Ensures timely initiation of deviations when quality issues are identified.
- Perform room and equipment releases and line clearance activities in support of on-time manufacturing.
- Review and release raw materials and components to be used in manufacturing.
- Distribute fully reviewed and executed quality documents and records to customers in accordance with company procedures.
- Participate in supplier quality assessments to ensure suppliers and subcontractors are properly qualified in accordance with the supplier management program.
- Generate, review and issue product labels for use in manufacturing.
- 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.
- 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.
- Perform other duties as assigned.
The job may involve the following:
- Working to 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 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.
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.