US ~ Boothwyn, PA
QA Manufacturing Specialist
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
Provides Quality Assurance support to the Formulation / Manufacturing Department. The main purpose of this position is to ensure GMP compliance of the manufacturing and warehouse area with respect to equipment, facility, manufacturing, and related documentation.
The office of this position will be located in the GMP manufacturing area.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned as appropriate.
Performs all room and equipment releases required for manufacturing.
Ensures that all the manufacturing and packaging activities are being conducted as per CGMP and SOPs.
Performs periodic checks on all the documentation being carried out by manufacturing personnel.
Performs required checks on all log books and entries to ensure conformance.
Checks and ensures that tasks are being performed by trained personnel.
Provides on the floor QA coverage during production activities such as label check, cleaning, etc.
Guides personnel in the GMP area regarding compliance items.
Provides day-to-day quality decisions related to manufacturing operations.
Reviews all manufacturing-related SOPs.
Other duties may include but not limited to the following:
Works with the warehouse personnel to ensure compliance.
Reviews Master Batch Records.
Reviews executed manufacturing batch records for completeness and ensures performance of operations according to batch records and applicable regulations and procedures; releases acceptable batch records.
Creates, issues, tracks, reviews, approves, and/or controls labeling materials.
Reviews and approves Quality-related documents, including but not limited to: protocols, qualification, validation and stability reports, and test results, including raw data; change control documentation; calibration certificates, and temperature charts.
Tracks and trends quality failure investigations, deviations, change controls (equipment), complaints, and recalls or field alerts.
Writes and reviews procedures and other controlled documents.
Periodic inspection of operations (including qualification and validation activities) to ensure compliance with written procedures, protocols, and regulatory requirements.
Inspects and releases clinical and manufacturing supplies, manufactured products, raw materials, and/or chemicals.
ADDITIONAL POSITION REQUIREMENTS
Provides QA guidance on validation activities
Performs GMP audits
Provides training, as needed, and keep track of individual training needs, including follow-up with department supervisors
Provides assistance to other personnel with regard to any Quality issues, including document retrieval and archival
Maintains accountability for clinical supplies
Plays an active role during regulatory and client inspections
Is available for other duties as required
EDUCATION and/or EXPERIENCE
B.A. or B.S. degree in a scientific field, e.g., pharmacy, chemistry, biology, or pharmacology and three (3) or more years related pharmaceutical industry experience preferably in solids product manufacturing.
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 in commercial manufacturing.
Experience with validations / qualifications (equipment/instrumentation/methods/process) in a cGMP environment.
Thorough knowledge and understanding of the current Good Manufacturing Practices (GMP), and/or 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.
While performing the duties of this job, the employee is frequently required to stand, walk, use hands to finger, handle or feel, and talk or hear.
The employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl and taste or smell.
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.