US ~ Boothwyn, PA
Our growing and successful business comprises of over 700 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, specializing 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.
GENERAL PURPOSE OF JOB
Perform data/document reviews, investigate/resolve non-conformances, and maintain change control systems. Ensure company adherence to Good Manufacturing Practices (GMPs), Good Documentation Practices, applicable regulatory standards, and internal procedures and practices.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
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.
ADDITIONAL POSITION REQUIREMENTS
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
Provide assistance to other personnel with regard to any Quality issues, including document retrieval and archival
Maintain accountability for clinical supplies
Play active role during regulatory and client inspections
Is available for other duties as required.
Is available for overtime as needed.
EDUCATION and/or EXPERIENCE
Specialist - B.A. or B.S. degree in a scientific field, e.g., chemistry, biology, or pharmacology and 2 years related work experience.
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.
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.
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.