QA Specialist I, QA Specialist II
Posting ID: JP-002179223
• Review batch records from external suppliers for cGMP compliance
• Review and assess deviations related to external API production
• Enter batch data into disposition system
• Summarize exception events in external event tracking system
Experience beneficial in: Veeva Vault, Trackwise
Prefer commercial API experience, working with contract manufacturing sites, deviation review and batch release
aseptic technique, quaity assurance, Quality assurance, Gmp, Fda, Capa, Batch record, Qa, Inspection, Sop, batch record review, BRR, aspetic
Additional Skills & Qualifications:
Help with Batch record review
Opening the records, uploading records using IQS (Integrated Quality System), updating status
Making recommendations for batch release then will go to manager who will release batch
-Drug substance experience would be nice
-experience with drug products
-some quality experience would be required-- a couple of years, batch release experience (2+ years)
If a person is looking for commercial experience this is a great chance for them.
They can get exposure to other aspects such as validation, qualification- dependent on person's drive
Amazing begins here. EASi is a leading global services company specializing in engineering and sciences. For more than 35 years, EASi has delivered critical services across a range of industries, including energy and utilities, transportation, heavy equipment, consumer and industrial products, medical devices, pharmaceutical and biotechnology, as well as academic and health care research. By adapting to the constantly evolving needs of our customers, we have built specialized expertise and a multidisciplinary perspective - leveraging cutting-edge technology and processes - to constantly improve and innovate. Through EASi's flexible solutions and consultative approach, customers in engineering and sciences can expect unparalleled quality, increased speed to market and collaborative customer engagement services.
Headquartered in Hanover, Maryland, EASi has 3,700 dedicated employees across North America, Europe and Asia. EASi is an Aerotek company, a leader in the recruiting and staffing industry. Aerotek is an operating company of Allegis Group® Inc., a global leader in talent solutions. To learn more about EASi, visit EASi.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Kristyn Snow