US ~ Boothwyn, PA
Senior QA Specialist - Commercial
Our growing and successful business comprises of over 900 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 Sr. QA Specialist will lead quality interactions with Quotient Sciences’ customers and ensure that contracted manufacturing and testing activities are conducted in accordance with current Good Manufacturing Practices (cGMP), Data Integrity requirements, other applicable standards and regulations, customer’s market authorization, and Quotient’s policies and procedures. The majority of projects will involve oral solid dosage pharmaceuticals. The Sr. QA Specialist will ensure efficient and effective implementation of regulatory requirements into the quality management system, proactively communicate compliance requirements across the organization, 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:
- Lead and participate in daily quality and compliance activities related to commercial operations, proactively identifying and working collaboratively to resolve compliance risks, and maintaining an effective cGMP Quality Management System.
- Review and approve Quality-related documents including, but not limited to, qualification and validation protocols and reports, stability reports, test results including raw data, change control documents, calibration OOT reports, and investigations.
- Provide QA leadership and participate in tech transfer activities to support customer registration, scale up, validation and commercialization readiness. Ensure robust process development and risk assessment activities to support the continued manufacturing of quality products.
- Provide QA oversight to the production of registration batches and commercial product to ensure that product is manufactured right the first time in accordance with specifications, our customer’s market authorizations and GMP requirements. Proactively identify and implement improvements to product quality and process reliability to minimize potential for errors or quality events.
- Assure timely issuance, resolution and closure of investigations (e.g. deviations, customer complaints), and CAPAs in response to supplier, manufacturing and/or laboratory discrepancies. Provide QA guidance and technical assistance to assure thorough root cause investigations and effective corrective actions to prevent recurrences. Collaborate with department leaders to identify effective corrective actions that meet regulatory requirements while maintaining organizational agility.
- Review and release materials and components to be used in the manufacture of commercial products.
- Review executed batch records, analytical test results and raw data,
- Conduct QA review and approval of master and executed batch records, analytical test results and raw data, and release product after ensuring all requirements have been fulfilled and product conforms to specifications. Ensure effective and reliable lot disposition and release activities for drug products within established timeframes to meet customer commitments.
- Host/co-host customer audits and regulatory inspections. Contribute to the effective resolution of and response to any audit/inspection findings. Ensure actions taken to address findings are implemented and sustained.
- Gather, analyze and report on data for Annual Product Quality Reviews (APQRs) in support of customer filings.
- Negotiate and execute late-stage customer Quality Agreements and ensure terms of Agreements are integrated into the QMS and consistently fulfilled.
- Identify, communicate, and escalate quality and compliance risks. Provide guidance for and participate in timely resolution, acting always with an appropriate sense of urgency.
- Ensure quality system processes and procedures in support of commercial operations consistently align with current regulatory requirements, industry best practices, and support efficient and effective execution.
- Support on-time manufacturing schedules by performing review and release of raw materials and components, room and equipment releases, and line clearance activities.
- Interpret and provide guidance, coaching and mentoring to other functions and, where necessary, customers on regulatory requirements and expectations.
- Ensure procedures that govern the manufacturing and testing of registration batches and commercial product are current to regulatory requirements, industry standards and best practices, and support efficient execution of work.
- Demonstrate quality is prioritized by providing thorough and accurate work product, challenging any observed compromise on quality and making recommendations for corrections or improvements.
- Coach and mentor other QA commercial 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; advanced degree and/or industry certification(s), such as those offered by AQS, preferred
- Minimum eight (8) 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.