Quality Control Manager/ Quality Supervisor
Blue Bix Elgin
Responsibilities
- Provides leadership, direction, and work hands-on in performing Quality functions including Incoming Inspection & Release, In-Process QA, Label Control, and Material Disposition.
- Monitors day-to-day manufacturing activities to assure production processes are in compliance with and followed as per the FDA guidelines, written standard operating procedures, and company policies
- Supervisory oversight of the quality team.
- Ensures raw materials used in the production of products are from qualified/approved vendors and meet internal quality testing specifications.
- Advises other departments about quality assurance issues that impact their realm of responsibility.
- All phases of documentation review and approval, including the creation of standard operating procedures for the Quality Assurance Department.
- Administers the Hydrox Investigation/CAPA program including final approval of all reports.
- Performs data analysis investigation of trends for root cause analysis, creating corrective/preventive actions, and ensuring the effectiveness of the actions for products.
- Creates standard operating procedures to ensure quality assurance compliance with current good manufacturing practices.
- Seek efficiency improvements in productivity and quality without compromising the FDA regulatory and compliance standards.
- Immediately communicate to management any issues or problems potentially impacting products, processes, and/or any activities for the organization.
- Interface with other departments to ensure information is communicated to these department heads concerning quality matters in a timely and complete fashion.
- Participates in audits conducted by regulatory agencies and consultants.
- Assists the VP of Quality in developing and implementing systems, evaluating procedures, plans and policies to ensure product integrity and compliance with the current FDA guidance.
- B.S. / B.A. in Science-related discipline with experience in a pharmaceutical/Food manufacturing organization.
- Thorough understanding of FDA cGMP regulations and experience in handling Regulatory inspections.
- Knowledge of pharmaceutical formulation and manufacturing processes.
- Minimum of 3years of supervisory or management experience in pharmaceutical/Food quality assurance.
- Versed in the regulatory requirements (cGMP) of the pharmaceutical industry, and will have demonstrated strength in problem solving and resolution.
- Must have proven interpersonal skills, and be able to direct the activities of subordinates.
- Able to perform statistical analysis in developing test levels and in performing investigations. Knowledge of Six Sigma Green Belt and lean tools.
- Excellent problem-solving aptitude, communication, and multi-tasking skills.
- Excellent verbal and written communication skills.
Benefits
Michael PageChicago, 37 mi from Elgin
this role offers the chance to transition into a more expansive corporate position within the organization.
Job Description
The Quality Control Manager will be responsible for:
• Develop and analyze statistical data and product specifications to set...
Michael PageChicago, 37 mi from Elgin
of a smaller organization. As they continue to expand, this Quality Control Manager position offers the potential to evolve into a broader corporate role within the company.
Job Description
Responsibilities for the Quality Control Manager Opening...
Michael PageChicago, 37 mi from Elgin
standards and expectations.
• Formulate and maintain quality control objectives that align with corporate goals.
• Ensure compliance with quality regulations, including ISO 9001:2015 and AS 9100:2016.
• Assist with ISO 9001:2015 and AS 9100:2016 audits...