QAS - 2019
US ~ Boothwyn, PA
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.
- Perform data/document reviews, investigate/resolve non-conformances, and maintain change control systems
- To comply & adhere to GXP guidelines and regulations as required of this role.
- Responsible for ensuring compliance through the Quality framework and follow procedures that govern the work performed in this role.
Main tasks and responsibilities:
- QA Specialist will review and approve Quality-related documents, including but not limited to: protocols; qualification, validation and stability reports; test results, including raw data; change control documentation; calibration certificates; and temperature charts.
- Track and trend out-of-specification results, quality failure investigations, out of specification results investigation, deviations, change controls (equipment), complaints, and recalls or field alerts.
- Write and review procedures and other controlled documents.
- Review Master Batch Records.
- Review executed manufacturing batch records for completeness and to ensure performance of operations according to batch records and applicable regulations and procedures; release acceptable batch records.
- Periodic inspection of operations (including qualification and validation activities) to ensure compliance with written procedures, protocols, and regulatory requirements.
- Create, issue, track, review, approve, and/or control labeling materials.
- Inspect and release clinical and manufacturing supplies, manufactured products, raw materials, and/or chemicals.
- Responsible for coordinating and training implementation activities with Manufacturing, Maintenance and Technical Operations that meet or exceed customer timelines.
- Authors investigative reports for all CAPA investigations that follow a consistent, format.
Other tasks and responsibilities will include:
- Provide QA guidance on validation activities
- Perform GMP audits
- Provide training, as needed, and keep track of individual training needs, including follow-up with department supervisors
- Play active role during regulatory and client inspections
- Read and interpret documents such as safety rules, operating and maintenance instructions, and standard operating procedure manuals.
- Write routine and technical reports and business correspondence and standard operating procedures manuals.
- Work with mathematical concepts such as probability and statistical inference.
- Apply concepts such as fractions, percentages, ratios and proportions to practical solutions.
- Define problems, collect data, establish facts and draw valid conclusions.
- Interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
- 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.
- B.S. degree in a scientific field, e.g., chemistry, biology, or pharmacology
- At least five (5) years related pharmaceutical industry experience desired
- M.S. degree in scientific field preferred
Other skills, abilities or qualifications:
- Experience with validations / qualifications (equipment/instrumentation/methods/process) in a cGMP environment.
- Thorough knowledge and understanding of the current Good Manufacturing Practices (GMP), and International Conference on Harmonization (ICH) guidelines.
- Experience working in manufacturing and/or laboratory environment.
- Familiarity with the production process.
- Successfully completes regulatory and job training requirements.
- Computer skills:
- Enter data into computer using software applications for data entry and word processing Microsoft Office, Software (Word, Access, Excel, Outlook, and PowerPoint).
- Work and be proficient with e-mail systems
- Ability to perform repetitive tasks while maintaining speed of work and attention to detail without loss to production.
- Ability to perform under stress in cases of emergency, critical or hazardous situations.
- Ability to work with others in a team 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.