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Senior Quality Assurance Scientist
The resources for this opportunity must meet the following minimum requirements in order to be considered:
Qualifications and Required Knowledge/Skills
Bachelor’s degree in science (e.g., Chemistry, Biology, Microbiology, Pharmacy) or Engineering, with six (6) years of experience in a role exercising GMP responsibilities in the pharmaceutical industry.
Three to five years of practical experience in Quality Systems (e.g., Investigations, CAPA, Change Control) in a GMP manufacturing environment.
Knowledge of manufacturing operations of Parenteral Products Manufacturing.
In-depth knowledge of cGMPs, FDA and EU regulations, and the ability to interpret and apply them for intended use.
Demonstrable skills in:
Problem solving
Critical thinking
Learning capability
Analytical thinking
Attention to detail in review of GMP documents (e.g., Deviation Reports (manual/electronic), SOPs, CAPAs, Logbooks, Reports, Batch Records)
Ability to identify which matters must be dealt with a sense of urgency; ability to work under fast-paced conditions and to quickly identify when Subject Matter Experts and/or Senior Management must be involved.
Self-starter with interpersonal skills and the ability to interact with people at all levels.
Fully bilingual (Spanish/English) with excellent written and verbal communication skills.
Proficient knowledge of computer systems (Microsoft Office, etc.) and applications such as Trackwise/Infinity and SAP.
Preferred Background
Knowledge and in-depth experience in various GMP processes (e.g., Change Control, Investigations), plus Lean/Six Sigma training or certifications.
**Weil Group is proud to be an Equal Employment Opportunity Employer.*
Qualifications and Required Knowledge/Skills
Bachelor’s degree in science (e.g., Chemistry, Biology, Microbiology, Pharmacy) or Engineering, with six (6) years of experience in a role exercising GMP responsibilities in the pharmaceutical industry.
Three to five years of practical experience in Quality Systems (e.g., Investigations, CAPA, Change Control) in a GMP manufacturing environment.
Knowledge of manufacturing operations of Parenteral Products Manufacturing.
In-depth knowledge of cGMPs, FDA and EU regulations, and the ability to interpret and apply them for intended use.
Demonstrable skills in:
Problem solving
Critical thinking
Learning capability
Analytical thinking
Attention to detail in review of GMP documents (e.g., Deviation Reports (manual/electronic), SOPs, CAPAs, Logbooks, Reports, Batch Records)
Ability to identify which matters must be dealt with a sense of urgency; ability to work under fast-paced conditions and to quickly identify when Subject Matter Experts and/or Senior Management must be involved.
Self-starter with interpersonal skills and the ability to interact with people at all levels.
Fully bilingual (Spanish/English) with excellent written and verbal communication skills.
Proficient knowledge of computer systems (Microsoft Office, etc.) and applications such as Trackwise/Infinity and SAP.
Preferred Background
Knowledge and in-depth experience in various GMP processes (e.g., Change Control, Investigations), plus Lean/Six Sigma training or certifications.
**Weil Group is proud to be an Equal Employment Opportunity Employer.*