Overview
Quality Assurance Specialist II Jobs in Georgia, United States at SoTalent
Title: Quality Assurance Specialist II
Company: SoTalent
Location: Georgia, United States
The individual will be responsible for upholding quality standards within production processes and essential facility systems, providing oversight and operational support. This includes identifying and evaluating compliance and quality risks based on regulatory guidelines and internal quality protocols. Support will be provided for production activities utilizing digital batch management systems, and mentorship will be offered to team members.
This role necessitates managing multiple projects, demonstrating proficiency in task execution, decision-making, team empowerment, exception handling, training, problem resolution, and team leadership.
Key Responsibilities:
Provide ongoing quality assurance support for production processes and critical facility systems.
Conduct thorough internal assessments and evaluations, gathering and analyzing objective evidence regarding risks through collaboration with production supervisors, engineering, and other internal departments.
Gather information through employee interviews, process mapping, and other data collection methods.
Review digital production records, identify deviations, and participate in investigations and corrective/preventive action initiatives.
Deliver training and coaching to employees on relevant procedures and standards.
Develop, review, analyze, and revise standard operating procedures (SOPs) to ensure compliance with corporate, divisional, plant, and regulatory requirements.
Oversee the review and auditing of various reports, including protocols, qualifications, and regulatory submissions.
Contribute to, coordinate, or lead quality assurance projects across multiple sites.
Perform other assigned duties and projects.
Apply critical thinking skills and understanding of production processes to make quality decisions based on regulatory knowledge and trends.
Collaborate with production, compliance, quality control laboratories, and technical services to ensure product quality and safety.
Qualifications:
Bachelor’s degree in a science or business-related field. Alternatively, 3+ years of quality experience in a medical device, pharmaceutical, or similarly regulated industry.
Strong teamwork, problem-solving, and communication skills.
Familiarity with electronic quality management systems and digital batch record management is preferred.
Detail-oriented with the ability to multitask.
Ability to track metrics and drive team and partner performance.
Strong interpersonal, communication, influencing, and negotiation skills.
Strong analytical and problem-solving abilities.
Ability to foster teamwork and drive decision-making.
Ability to manage multiple concurrent projects.
Proficiency in Microsoft Word, Excel, and PowerPoint.
Knowledge of electronic quality systems, process control systems, and digital batch record management.
Understanding of regulatory guidelines, good laboratory practices, and good manufacturing practices.
