QA /QC Specialist
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location: Exton, Pennsylvania
job type: Contract
salary: $37.06 - 43.60 per hour
work hours: 8 to 4
Small molecule API and drug product lab testing experience is a must, HPLC, GC, FTIR, KF, dissolution, etc.
Has experience review data, experienced in working with CMOs and 3rd party testing labs. Experienced in lab troubleshooting, investigations.
GMP compliance, familiar with regulations and ICH guidelines.
This position is responsible for oversight of QC activities conducted at CMO labs and contract test labs
(CTLs) for drug product and APIs. Provide technical support and quality oversight to third part testing
- Primary duties of the position are focused around non-laboratory support of the QC functions.
Primary activities would generally include but not limited to data analysis, data trending, project
and testing coordination, product and material specification management, inspection support,
investigation leads, operational excellence leads, document revisions, initiating/completing quality
systems, method/equipment validation and method projects activities.
- Lead or support analytical and manufacturing investigations of unexpected results to identify root
cause (e.g. Out Of Specification (OOS)/Atypical (AT) laboratory investigations) and defines and
implements corrective or preventive actions. Provide impact assessment and help drive to
- Develops testing plans and support method transfers as needed. Authoring analytical protocols,
stability protocols. study plans, reports.
- Responsible to initiate change controls, deviations and maintain compliance in Quality Systems.
- Support regulatory filings and RTQs.
- Create purchase order and reconcile invoices
- Bachelor's Degree in Chemistry, Biology, or related discipline.
- 5+ years experience in in the pharmaceutical industry and/or QA/QC laboratory environment.
- Must have good understanding of a variety of analytical techniques such as HPLC, dissolution,
GC. KF, FTIR
- Experience in analytical laboratory, method execution, qualification and/or validation of small
molecule or biologics assays.
- Experience managing analytical activities conducted by third party testing laboratories.
- Strong communication and technical writing skills. Strong verbal and written communication skills
with the ability to communicate ideas and data in a persuasive, organized, and appropriate
- Ability to thoughtfully analyze a wide variety of information and data to make key decisions.
Experience in cross functional team working environment and matrix management.
- Awareness of financial processes.
- General understanding of applicable regulations and guidance.
- Strong proficiency in Microsoft tools, especially Word and Excel.
- Knowledge of Laboratory Information Systems (LIMs) is a plus.
skills: HPLC, Laboratory Information Management Systems (LIMS)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.