US ~ Garnet Valley, PA
QA Specialist - Clinical
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 Specialist will represent Quotient Sciences QA 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 QA Specialist will ensure efficient and effective implementation of regulatory requirements into the quality management system, proactively communicate compliance requirements to the project team, and serve as a role model for the behaviors necessary to maintain compliant GMP practices and advance the quality culture.
Main tasks and responsibilities will include:
- Serve as the QA representative on project teams for early phase pharmaceutical formulation, development and manufacturing in support of clinical trials. Actively participate in project meetings.
- Ensure all deliverables required for the success of the project are satisfactorily completed on time by conducting timely review, feedback and approval of master batch records, pharmaceutical development reports, equipment qualifications, analytical method qualifications, process verifications, stability study documents, risk assessments, product specifications, and SOPs. Lead negotiation and assure execution of Quality Agreements with customers. Assure suppliers and subcontractors to be used for the clinical product are properly qualified in accordance with the supplier management program.
- Ensure quality expectations for clinical projects is clearly understood across the project team and with the customer. As required, tailor communication methods in order to share compelling messages and gain buy in.
- Review and release materials and components to be used in the manufacture of clinical trial material.
- Review executed batch records, analytical test results and raw data, and release product after ensuring all requirements have been fulfilled and product conforms to specifications.
- Participate in investigations related to deviations, out-of-specifications or atypical results related to the clinical trial product. Provide guidance for timely and thorough issue resolution including CAPAs to minimize potential for issue recurrence, acting always with an appropriate sense of urgency. Review and approve investigation reports.
- For products moving from early to late stage, participate in tech transfer activities to support customer registration, scale up, validation and commercialization readiness.
- Interpret and provide guidance, coaching and mentoring to other functions and, where necessary, customers on regulatory requirements and expectations.
- Ensure procedures that govern the formulation, development and manufacturing of clinical trial material are current to regulatory requirements, industry standards and best practices, and support efficient execution of work.
- Participate in the planning and execution of customer audits related to clinical projects. Maintain accountability to ensure responses to customer audit findings for clinical projects are complete and timely.
- Participate in regulatory inspections to ensure successful results.
- Develop productive, dynamic, professional working relationships founded in trust and respect with project team personnel and customers.
- Demonstrate quality is prioritized by providing thorough and accurate work product, challenging any observed compromise on quality and making recommendations for corrections or improvements.
- Work effectively with other QA clinical personnel and assure alignment and consistent decision making within the team.
- 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.
- B.S. degree in a scientific field, e.g., chemistry, biology, or pharmacology;
- Minimum six (6) years’ related experience in QA in CTM manufacturing or CMC roles experience
- Strong working knowledge of pharmaceutical quality systems, CGMP requirements, CMC requirements, 21 CFR Part 11, Annex 11, Data Integrity, and Quality by Design (QbD).
- Understanding of analytical chemistry and instrument analysis, including HPLC, GC, LC-MS and other chromatographic techniques. Familiarity with spectroscopic techniques desirable.
- Experience in solid dose manufacturing desirable.
- Excellent written and oral communication skills
- Self-directed and strong ability to work effectively across multiple cultures and with cross-functional teams
- Strong interpersonal skills with a special focus on customer satisfaction.
- Effective persuasion and influence skills
- Ability to multi-task and work in a fast-paced environment.
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.