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Determines and maintains quality standards developed in compliance with current Good Manufacturing Practices, the Company's own Standard Operating Procedures, and customer requirements. Provides resolution to quality deviations/issues. Recommends solutions based on SOP / cGMP requirements.
Job Responsibility:
Coordinates the daily activities of the QA Auditors
Assists with the daily activities of Production Inspection personnel for packaging
Implements inspection criteria and testing
Study and standardize departmental work practices to improve the quality and efficiencies of subordinates
Helps resolve quality-related issues with other departments and customers. Motivates, develops and provides continuous training either through the use of departmental work instructions, examination of cGMP's and SOP's, specific customer requirements or by personal instruction
Review records for accuracy of information, compliance with established procedures
Reviews daily paperwork to assure all customer requirements and quality standards have been met and maintained
Promotes continuity of shifts through cooperation and communication within as well as with other departments
Assist in the performance of monthly internal audits and any necessary corrective action to follow-up
Oversees Pest Control and Environmental (humidity, temperature, MKT). Monitoring Programs May disposition NMR's
Recommend and participate in disciplinary activities of subordinates
Maintain testing equipment and supplies needed for the department
May assist in performing investigations, may write reports, memos, or letters. This position may require overtime and/or weekend work
Carries out essential functions of the Quality Operations Manager in his/her absence
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules
Attendance to work is an essential function of this position
Perform Quality Health Check assessments to identify if processes and day to day activities are performed according to procedures
Performs other duties as assigned by Manager/Supervisor
Requirements:
Bachelor's Degree in a related field and/or 1-5 years related experience and/or training
College Level Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms
High Standard of Report Writing
Nice to have:
Ability to effectively present information to various people as the job requires
Ability to work independently and/or as part of a team
Ability to display a willingness to make decisions
Ability to display excellent time management skills
What we offer:
paid time off
health insurance coverage (including dental and vision)