Senior Specialist Quality Assurance III
Spectraforce
Durham, North Carolina
17 days ago
Job Description
Senior Specialist Quality Assurance III
Durham, NC 27712
6 months
Qualifications:
Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years experience in the Pharmaceutical Industry. Would consider Associates w/good relevant experience
Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing, sterile process validation and/or sterile process technology transfer.
Responsibilities:
Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products.
• Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Must have very strong relationship building skills.
Responsibilities to include but not limited to the following:
• Batch record review/approval
• Technical protocol review/approval
• Equipment qualification protocol review/approval
• Deviation review/approval
• Execute shop floor quality audits
Comments/Special Instructions
familiar w/SAP. PAS-X, Manufacturing Execution System would be a plus, familiar with SAP a plus These positions are more traditional Quality Assurance type stuff as the project has moved past most of the qualification stages...
• Batch record review/approval
• Technical protocol review/approval
• Equipment qualification protocol review/approval
• Deviation review/approval
• Execute shop floor quality audits
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/hr.
Durham, NC 27712
6 months
Qualifications:
Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years experience in the Pharmaceutical Industry. Would consider Associates w/good relevant experience
Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing, sterile process validation and/or sterile process technology transfer.
Responsibilities:
Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products.
• Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Must have very strong relationship building skills.
Responsibilities to include but not limited to the following:
• Batch record review/approval
• Technical protocol review/approval
• Equipment qualification protocol review/approval
• Deviation review/approval
• Execute shop floor quality audits
Comments/Special Instructions
familiar w/SAP. PAS-X, Manufacturing Execution System would be a plus, familiar with SAP a plus These positions are more traditional Quality Assurance type stuff as the project has moved past most of the qualification stages...
• Batch record review/approval
• Technical protocol review/approval
• Equipment qualification protocol review/approval
• Deviation review/approval
• Execute shop floor quality audits
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/hr.