We are searching for a QES Manager to join a growing biotech company in Gaithersburg, MD!
Title: QES Manager
Location: Gaithersburg, MD (on-site)
Type: Direct Hire
The QES Manager is responsible for managing the Quality Management System, Environmental Management System, certifications and operational quality assurance in processes and products, and the Safety Program for the company.
Role 1: Quality System Management
• Work independently to evaluate, maintain, and enhance Quality Management System (QMS) and related processes and procedures.
• Schedule and manage internal and external audits.
• Manage the Non-Conformity database, ensuring that corrective actions are executed on a timely fashion by the responsible organizations.
• Maintain Document Control for QMS and other business documents.
• Participate in the Quality Improvement meetings for various departments and participate in problem-solving where relevant.
• Manage relationships with ISO auditors and other third parties to ensure maintenance of ISO 9001 certification
Role 2: Environmental System Management
• Identify, determine, evaluate, and control all environmental aspects and their impacts, in compliance with OSHA and local regulations.
• Responsible for environmental certification processes and renewals with local, state and federal authorities as needed
• Control and monitor of the complaint handling process
Role 3: Safety Oversight
• Manage Safety Programs for the company
• Perform regularly scheduled risk assessments at all locations of the company
• Develop programs to ensure safety is established as a core tenet of company work procedures
• Ensure all stakeholders comply with the safety statutory and regulatory requirements
• Provide input in the assessment of all new chemicals and equipment to be brought into the facility to ensure they are being handled safely
Role 4: Quality Assurance
• Develop procedures and establish criteria to be managed by the manufacturing QC team to ensure products conform to specifications
• Assure reliability and consistency of production by checking processes and outputs
• Responsible for operational quality assurance in processes and products.
• Communicate with the different departments about the performance and quality of the products and monitor/control that quality standards are followed correctly and are met.
• Ensure that the processes of external suppliers meet the organization's quality standards.
Role 5: Communication and Training
• Responsible for developing and leading training programs for quality, safety, and safety for employees and suppliers
• Perform and record regular training of employees
• Lead company events focused on QES such as annual Safety Day, Lab Cleanout, etc.
• Minimum Associates Degree in Quality/Industrial Management and Engineering
• Minimum of 5 years in a quality function preferably in a manufacturing environment and experience in quality management system; ISO audit, within a manufacturing environment; document control; Incoming/In-process/Outgoing quality control; EMS
• Internal Auditor qualification for ISO 9001
• Proficient in MS Office (Excel, PowerPoint, Word, Outlook, etc.)
• Good interpersonal and communication skills with all levels of people
• HAZWOPER certification
• The ability to work in a manufacturing facility, lift 25 lbs. and climb ladders as necessary
• Experience working in food-grade manufacturing facilities and with GMP processes
• Eligible to work is U.S
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at email@example.com or 844-463-6178.