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Quality Assurance Auditor
Job Responsibilities: Review cGMP regulated
documents, such as, analytical methods, data, and reports,
batch records, packaging records, SOPs, stability protocols
and reports, validation protocols and reports. Perform internal
and external GMP audits. Release GMP processing rooms and
equipment. Interact with Formulation and Analytical R&D personnel
to comply with all cGMP Guidance/regulations. Requirements:
BS/BA in Chemistry, Biology, Pharmacy or related field and
0 - 5 years of pharmaceutical industry experience. Experience
in QA preferred. s
Product Development Scientist
Responsible for developing formulations and
manufacturing process for oral dosage forms to meet customer
needs. Perform pre-formulation, formulation, manufacturing
process development/optimization for various batch sizes (lab
to production scale), equipment and process validation under
strict cGMP guidelines, write SOPs/batch records/protocols/reports/submission
documents for IND/ANDA/NDA, prepare and monitor stability
protocols per ICH guidelines, evaluate packaging components,
interact and coordinate project activities with analytical
scientists, QA and customers, and transfer technology/process
to manufacturing sites.
MS/PhD in Chemistry, Pharmacy/Pharmaceutical
Sciences or any related field. 1-3 years experience in the
pharmaceutical industry
Manufacturing Technical Associate
Responsible for pharmaceutical manufacturing
of oral dosage forms under strict cGMP guidelines.
Perform product manufacturing using small to
large scale equipment, prepare manufacturing batch records
and process development reports, order/receive/inventory raw
materials, comply with SOPs, and maintain clean cGMP area
and equipment complying with cGMP standards.
High School diploma/BS. Knowledge of cGMP,
SOPs or Experience in pharmaceutical manufacturing is a plus.
Analytical Scientist
This is a hands-on scientist entry level position
involved in all facets of analytical support for pharmaceutical
product development. Responsibilities include: instrument
calibration and maintenance; analytical method development
and validation for API and drug product; analytical testing
to support product development and drug discovery; and serving
as a technical and scientific resource to other departments
within the company. Requires B.S. in Medical Technology, Chemistry,
Pharmacy or equivalent with 0-5 years of industrial pharmaceutical
laboratory experience. Knowledge of experiment documentation,
HPLC method development and validation, HPLC troubleshooting
and an understanding of GMP, GLP and ICH guidelines desired.
Other desired skills include dissolution, UV-VIS, KF, particle
size analysis, thermal analysis and headspace GC.
How to apply
QS Pharma is an equal opportunity employer.
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