Shift: Monday-Friday 8-5
Fully onsite
Key Responsibilities:
Identify and document deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines.
Conduct thorough investigations to determine the root cause of deviations.
Collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs).
Documentation and Reporting:
Maintain accurate and detailed records of all deviations, investigations, and CAPAs.
Prepare and present deviation reports to management and regulatory authorities as required.
Ensure documentation is completed in accordance with Good Documentation Practices (GDP).
Compliance and Quality Assurance:
Ensure all deviations are managed in compliance with company policies, industry standards, and regulatory requirements.
Participate in internal and external audits and inspections, providing necessary documentation and information related to deviations.
Continuous Improvement:
Analyze deviation trends and provide insights for continuous improvement initiatives.
Participate in training programs to enhance knowledge and skills related to deviation management and quality assurance.
Qualifications:
Regulated Industry, cGMP environment experience, deviation management, or a e.g., Pharmaceuticals, Manufacturing, Engineering, Medical, Law Enforcement, etc.].
Strong Attention to details, technical writing, Analytical and problem-solving skills.
Knowledge of regulatory requirements and standards.
Intermediate to Advanced skills in Microsoft Suite (Word, Excel, PowerPoint)
Excellent communication and interpersonal skills.
Preferred Qualifications:
Associate or bachelor's degree in a relevant field such as Life Sciences, Engineering, Medial, or Quality Management with 2+ years of related experience.
Preferred Experience: Biologics, Aseptic, Filling Isolators, Six Sigma Certification, Electronic documentation systems.
Familiarity with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
...market. Responsible for delivering custom quotes, detailed proposals, and pricing negotiations. Engage with clients through a consultative sales process acting as a subject matter expert and solution provider. Coordinate sales efforts and project schedule with...
...Responsibilities Manage large amounts of customer interactions Generate sales and leads... ...methods/tools Meet personal/customer service team sales targets and call handling... ...Weekly day range: ~ Weekends as needed Work setting: ~ Office Ability to...
...lifting and or carrying single items weighing at least 50 lbs., as well as functions and activities such as pulling, pushing, bending, standing, lifting, reaching, and stooping, kneeling, crouching, or crawling. Who we are: For more than 77 years, Best-One Tire &...
...Bonus based on performance~Company car~Competitive salary~Dental insurance~Flexible schedule~Free uniforms~Health insurance... ...~Vision insuranceTake everything you ever learned about sales and throw it in the gutter! Imagine a sale where 95% of the leads...
Description: The TSUBAKI name is synonymous with excellence in quality, dependability, and customer service. U.S. Tsubaki is a leading manufacturer and supplier of power transmission and motion control products. As a part of a vast, international network of corporate and...