- Directs and coordinates the activities of the quality control function to ensure achievement of company objectives.
- Ensures that quality system requirements are maintained and reported.
- Evaluates current procedures and practices for accomplishing department objectives; develops and implements improvements as needed.
- Develops and implements primary quality control systems consistent with GXP (GMP, GLP, GCP) and SOPs.
- Generates protocols, reports, and SOPs; reviews protocols, SOPs, product specifications, and batch records.
- Ensures that cGMPs are always met.
- Directs and coordinates analysis of products in compliance with cGMP regulations and SOPs.
- Identifies technical problems and develops solutions.
- Reviews all data generated in support of method validation and stability studies; oversees preparation of technical reports and summaries based on data.
- Oversees completion of appropriate documentation to support testing procedures.
- Develops and maintains department budget.
- Manages laboratory equipment maintenance schedules; ensures laboratory equipment is maintained in accordance with established schedules, GMP requirements, and SOPs.
- Participates in GMP audits.
- Hires, trains, supervises, motivates, and develops quality control staff; manages schedules and workflow.
- Assigns duties and monitors quality of work; assures staff conforms to organizational policies and procedures and government regulations.
- Provides day-to-day guidance and oversight of subordinates; actively works to promote and recognize performance.
- Keeps up to date on overall activities of the team, identifying problem areas and taking corrective actions.
- Performs other related duties as assigned by management.
- Bachelors/Ph.D./M.S. in related field and minimum of two to six years related experience.
- Strong knowledge of manufacturing processes, computer and
- Thorough knowledge of GMP, CFR, and factors impacting compliance.
- Knowledge of and ability to utilize statistic in evaluation of data.
- Thorough knowledge of FDA regulations.
- Experience with laboratory environment, equipment and safety procedures.
- Experience in research and development, including understanding of statistical
- Demonstrated proficiency in supervising and motivating subordinates
- Basic competence in subordinates' duties and tasks
- Commitment to excellence and high standards
- Excellent written and oral communication skills
- Strong organizational, problem-solving, and analytical skills
- Ability to manage priorities and workflow
- Versatility, flexibility, and a willingness to work within constantly changing
- Acute attention to detail
- Demonstrated ability to plan and organize projects
- Ability to work independently and as a member of various teams and committees
- Proficient in Excel, Dynamics GP experience a plus
- Proven ability to handle multiple projects and meet deadlines
- Working knowledge of data collection, data analysis, evaluation, and scientific method.
- Ability to develop clear, concise, and timely oral and written reports.
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Quality Control Lead - Tampa, United States - Trademark Recruiting/Consulting
Description
Trademark Recruiting is conducting a search for a well established and respected manufacturing company headquartered in Tampa, Fl. Our client is looking to bring on a Quality Control Lead who will work closely with the Director of Operations, as well as the Director of Procurement. This person will play an integral role in assuring the quality and consistency of company operations continue to exceed standards.
JOB TITLE: Quality Control Lead
SUMMARY: Leads and coordinates the activities and operations of the quality control department and staff.
DUTIES AND RESPONSIBILITIES:
QUALIFICATIONS:
equipment validation, GMPs, and product/process validation.
analysis.
priorities with enthusiasm