Senior QA Specialist

Quotient Sciences

Posted on: September 23, 2022

Closing: October 23, 2022

Salary: Undisclosed

Position Type: Full Time

Job Description

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, 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

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 in various stages of development, from pre-formulation through commercial.  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:

  • Serve as the lead QA representative on project teams for early phase pharmaceutical formulation, development and clinical/ commercial manufacturing.  Actively participate in project meetings.  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.
  • Lead and participate in daily quality and compliance activities related to formulation development activities, clinical trial manufacturing operations, and commercial operations, proactively identifying and working collaboratively to resolve compliance risks, and maintaining an effective cGMP Quality Management System.
  • 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, qualification and validation protocols test results including raw data, change control documents, calibration OOT reports, investigations and SOPs
  • Guide and participate in daily quality and compliance activities related to formulation development activities, clinical trial manufacturing operations, and commercial operations, proactively identifying and working collaboratively to resolve compliance risks, and maintaining an effective cGMP Quality Management System.
  • 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, qualification and validation protocols test results including raw data, change control documents, calibration OOT reports, investigations and SOPs.
  • Lead and negotiation and assure execution of Quality Agreements with customers.  Assure suppliers and subcontractors to be used are properly qualified in accordance with the supplier management program.
  • Interpret and provide guidance, coaching and mentoring to other functions and, where necessary, customers on regulatory requirements and expectations Review and release materials and components to be used in the manufacture of clinical trial material
  •  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 clinical 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.
  • 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 all products. 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 approve investigation reports.
  • Participate in the planning and execution of customer audits related to all projects.  Maintain accountability to ensure responses to customer audit findings for clinical projects are complete and timely.
  • Lead customer audits and participate in regulatory inspections.  Contribute to the effective resolution of and response to any audit/inspection findings. Being responsible for the customer responses and followups. 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.
  • 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 manufacturing 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 clinical trial batches, registration batches and commercial product are current to regulatory requirements, industry standards and best practices, and support efficient execution of work.
  • 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 Quality personnel and assure alignment and consistent decision making within the team
  • Perform other duties as assigned

 

The Candidate

  • 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 manufacturing or CMC roles experience
  • Advanced degree and/or industry certification(s), such as those offered by AQS, preferred
  • 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.

 

Company benefits

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.

Quotient Sciences

Posted on: September 23, 2022

Closing: October 23, 2022

Salary($): Undisclosed

Position Type: Full Time

Career Focus: Chemistry, Manufacturing, Quality

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