QA/Formulations Specialist x2 Details

QA/Formulations Specialist x2

splintpharma - Baltimore, MD

Employment Type : Full-Time

Job Opening for QA/Formulations Specialist x2 (2nd & 3rd Shift), Baltimore, MD

We are currently working on the job opening i.,e. Job Opening for QA/Formulations Specialist x2 (2nd & 3rd Shift), Baltimore, MD . Please let me know if you are interested in applying for the same.
Location: Baltimore, MD -
Consultant Title: QA/Formulations Specialist x2 (2nd & 3rd Shift)
Duration: 6 + Months
Day to day responsibilities:
Ideal candidate should have QA/ Formulations experience and will need to provide "real time" product formulation aseptic technique activities oversight
The Quality Assurance On the Floor (OTF) Specialist roles provide real time Quality oversight during the formulation and filling operations of production in an aseptic environment.
The QA OTF Specialist roles ensure that operations are executed in accordance with cGMPs; makes real time decisions on GDP, GMP and quality compliance issues; and possesses knowledge of both US and international regulatory guidelines and standards.
Provide QA oversight of aseptic processing including QA audit program
Execute AQL sampling and inspection of finished drug product
Conduct real time review of batch records, logbooks, and other associated GMP documents
Assist quality investigations related to deviations and environmental monitoring excursions
Accountable for maintaining training compliance including training seasonal staff
Demonstrates ability to work independently and within a team environment
SOP creation and revision and Validation documentation review
Additionally, this candidate will provide training and coaching to manufacturing personnel on techniques.
This candidates must also have received ISO 5 gowning certification in the last 3 years and have sterile product mfg. experience.