The Spear Group Specialist Quality Assurance, with guidance from the Quality Assurance Leader, ensures product/process quality through the review of GMP documents, facilities and processes and performs activities to ensure the reliable release of quality products to the marketplace. He/she is responsible for ensuring adherence to Divisional, Company and Site policy, procedures, and guidelines.
The Quality Assurance Specialist position requires strong collaboration, communication, and decision making attributes. Key elements of this position are also detailed process and facility knowledge and frequent shop floor presence.
PRIMARY ACTIVITIES:
Acts as a Quality contact for their area of support. As such, he/she must have sound knowledge of process, GMP systems, regulatory guidelines, design standards, company policies, as well as local SOPs . He/she is accountable for the shared operations, quality, and technology objectives for their area, including deviation and discard reduction, schedule adherence, cycle time reductions and right first time. Aids in coordination and execution of Quality Operations activities to ensure production plans are met, utilizing the tier process. Supports project work in the building.
Performs review and approval for batch records, auxiliary forms, deviations, CAPAs, change requests, validation protocols, etc.
Performs GMP walkthrough inspections to ensure compliance with cGMPs and regulatory requirements.
Actively participates in site inspections/audits by fulfilling requests for information.
Review, approve SOPs and other instructional documents for shop floor.
Provides training to various groups as needed and ensures compliance with departmental procedures.
Position Qualifications:
Education Minimum Requirement: Bachelor’s degree required - concentration in Chemistry, Chemical Engineering, Pharmacy, Biology, Microbiology, or equivalent preferred.
Preferred Experience and Skills: Experience in the pharmaceutical industry with knowledge of Quality Systems, Quality Assurance, and Quality Control including regulatory requirements. Exposure to SAP and project management.
Salary: Competitive Salary offerings
Benefits:Paid Leave, 401-K, Group Medical, Dental, Vision, Life, AD&D, etc.
