Quality Assurance Specialist
Spear Group-Contract Full Time /
Build a rewarding career
The Spear Group is a subsidiary organization of Sparus Holdings. Sparus Holdings is a leading provider of outsourced field and professional services primarily focused on the gas and electric utility markets. Sparus goes to market under seven core brands – Southern Cross, NAFS, The Spear Group, OneVision, TruCheck, ULS, and Allegiant. Its subsidiaries provide a unique blend of differentiated, yet complementary services to offer a tightly integrated solution set for its customers while expanding its addressable market and future growth prospects.
The Spear Group hopes to present you with the next opportunity for your career. When you partner with the Spear Group for your next role, you’ll be working alongside an experienced team who truly understands the challenges of your sector. We’ll take the time to appreciate the types of projects you enjoy, as well as the work environments you thrive in. With over 30 years of experience, we have deep networks and serve top-tier companies across North America. Explore our current postings and submit your resume to start the conversation today.
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.
EQUAL OPPORTUNITY EMPLOYER
The Spear Group, Inc. is an Equal Opportunity Employers. All personnel actions are effected without regard to race, color, sex, age, religion, national origin, disability, veteran status, or other protected status pursuant to law. As a responsible organization, we resolutely support the concept and practice of Equal Employment Opportunity. We uphold federal, state, and local civil rights laws and work to ensure that all of our personnel actions and policies are in compliance. Additionally, we recognize and value the importance and diversity of our work force and support its various cultures. The Companies are dedicated to fostering an environment that respects the dignity, rights and contributions of our employees.
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