Quality Assurance Specialist

Quality Assurance Specialist ROCGJP00039210

• Hourly pay: $35-$40/hr
• Worksite: Leading biotechnology company (Philadelphia, PA 19104 - Onsite)
• W2 Employment, Group Medical, Dental, Vision, Life, Retirement Savings Program, PSL
• 40 hours/week, 10 Month Assignment

A leading biotechnology company is seeking a Quality Assurance Specialist. The successful candidate will provide quality, technical support, and oversight during manufacturing activities.

Quality Assurance Specialist Responsibilities:

• Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition.
• Open deviations as appropriate based upon Manufacturing Team and/or CMO notification; provide evidence of document closing at time of product disposition.
• Assure all deviation/investigations, change controls, CAPAs, and/or other required documentation are completed and closed before material/lot release.
• Review and evaluate QC testing records and any associated OOS investigations.
• Review, write, revise, and approve SOP’s, technical documents, and reports.
• Perform inspection and release of materials used for production, and review vendor certificates for completeness/compliance against approved specifications, and collaborate with Material Management to release incoming materials for production.

Quality Assurance Specialist Qualifications:

• 3-5 years in a regulated manufacturing environment with exposure to the Quality and Manufacturing field.
• Bachelor’s Degree in a scientific discipline.
• Pharma background preferred.
• Knowledge of Quality Systems such as Change Control, Investigations, and CAPA.
• Ability to communicate effectively witha wide range of personnel;
• Technical writing skills related to investigation reports.
• General working knowledge of relevant governmental regulations, cGMP, and guidelines.
• Ability to participate in cross-functional teams in root cause analysis and solution identification.
• Ability to work collaboratively in the process of conflict resolution to resolve deviations, effectively CAPAs, and identify requirements to implement changes in a controlled GMP environment.

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