Process Technician

Job Code: 2269

Location: St. Louis, MO

Job Function: The purpose of this job is to provide support to Senior Process Technicians in the Media Production Dept.  

Job Qualifications: Basic laboratory techniqueBasic laboratory safety understandingUse of standard laboratory equipmentKnowledge of the company’s quality systemHigh school diploma, 3 years general laboratory knowledge. Associates degree preferred

Full-time

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Regulatory Affairs Specialist

Job Code: 2300

Location: Durham, NC

Job Responsibilities:Organize and conduct training programs for employees in the area of employee orientation, ethics, GMP and ISO, team building, and other compliance and general training topic. Design and delivers Quality System training programs to all levels of personnel. Deliver in-depth management and development training to the cross-functional organizations at regional and/or national level as needed. Develops training tests. Maintains quarterly training reports to management. Responsible for ensuring personal and company compliance with all Federal, State local and company, regulations, policies, and procedures for Health, Safety and Environmental compliance.

Job Qualifications: BS degree with a minimum of 6 years of related training experience and/or equivalent Combination of education and experience. Strong working knowledge of code of federal regulations (21 Part 620 and 820).

Full-time

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Associate Director of Regulatory Affairs

Job Code: 141-06

Location: Durham, NC

Job Responsibilities:Responsible for the coordination and preparation of complex regulatory submissions and technical files for new and existing products. Ensures timely preparation of organized and scientifically valid submission. Interacts directly with regulatory agencies on specific product submissions. Evaluates and approves proposed changes to products and controlled documents. Reviews and approves labeling and promotional material. Evaluates reports of internal and external problem products and assists in product investigations to determine the need for field corrective action. Provides advice to and represents RA on specific project teams. Creates, monitors and controls Regulatory project schedules. Monitors change in the regulatory environment, valuate impact and communicate to interested parties.

Job Qualifications: Bachelors degree in a scientific discipline or equivalent combination of education and experience. Minimum seven years regulatory experience in medical devices, In-Vitro Diagnostic devices required. Minimum two years supervisory experience required. Excellent verbal and written communication skills required. International registration experience required. Experience in Labeling reviews, 510K submissions, PMA submissions required. Good negotiation and diplomatic skills. Must have good PC skills and be proficient in Office Windows, particularly Word and Excel. Excellent organizational and presentation skills required.

Full-time

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 Application Specialist - Industry

Job Code:     

Location: St.Louis, MO

Job Responsibilities: Respond to internal and external customer inquiries by providing training, troubleshooting, and consulting.  Maintain regulatory compliance and statistical analysis of data.

Job Qualifications: BS in microbiology or closely related Life Science.0-1 years of industrial microbiology experience, including standard methods.Experience with PC’sGood interpersonal and diplomacy skills.Good written and oral communication skills.Organizational skills.Problem solving skills.Teaching and consulting skills.Thorough knowledge of bMx Industrial products.

Full-time

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 Assoc. Staff QA Spec - Doc Control

Job Code:   018 

Location: St.Louis, MO

Job Responsibilities: The primary purpose of this position is to analyze process and product documentation with the objective of maintenance and improvement of documentation and the Quality System.

Job Qualifications: Minimum BA/BS in a technical field or equivalent in a similar work environment.  Minimum 8 years of applicable industry experience – QA/QC experience is preferred.ASQ Certification of Quality Improvement Associate – CQIA, Quality Process Analyst – CQPA, Quality Auditor – CQA or Quality Engineer- CQE is recommended.  Computer skills including use of Microsoft Word and Excel and email.   Good verbal and written communication skills.  Good interpersonal skills for professional interaction with other departments/employees.  Ability to perform basic mathematical computations.  Knowledge and experience with ISO 9001/ ISO 13485 and FDA Regulations.  Leadership skills required.  Must be capable of creating and executing training and presentations.

Full-time

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 Group Leader Micro QC Lab

Job Code:    2137 

Location: St.Louis, MO

Job Responsibilities: This position is a working Group Leader of a subset of a department.  This position is responsible for hiring, firing, disciplinary actions, daily supervision of the department and includes all responsibilities of subordinates, in addition to providing group direction, training, leadership and coordination.  This specific position is responsible for fulfilling the working responsibilities of a Sr. Microbiologist in the Micro QC Dept. as well as supervise a subset of that department.  Individual must inspect/test/audit materials & processes in a timely fashion, while, at the same time, ensuring conformance to all requirements, applying product and process knowledge that is typically only acquired over tenure in the organization.

Job Qualifications: Minimum BS/BA degree in Biology/Microbiology/Chemistry or 6 years equivalent experience in a laboratory environment. Minimum 6 years of laboratory experience. Computer skills including use of Microsoft Office and email. Knowledge of aseptic techniques. Familiarity with handling of organisms.   Ability to maintain workload and pace with changing schedules. Working knowledge of STL change control process. Thorough knowledge of QC testing system for disposable STL products. Knowledge and experience in managing the disposition of nonconforming material; participate in material review board activities representing the QC function.·

Full-time

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 Manager Micro QC

Job Code:    024 

Location: St.Louis, MO

Job Responsibilities: Manage the personnel, material resources and operations of the Micro Quality Control Dept, to assure conformance to all regulatory, quality system, design & Process requirements.  Develop, implement and monitor the performance of Quality Control processes and requirements to assure Disposable products meet bioMerieux, FDA and ISO Quality System Requirements, meet the needs of internal and external customers, and manufactured products are compliant with product specifications.  Develop and maintain quality performance metrics to provide management and engineering a method of assessing the effectiveness of production processes and operator performance.  Provide liason for QC, Mfg. Operations, Industrialization Materials Dept in Quality related matters and identifying methods and resources to control product quality and costs.  Responsible for managing Quality Control personnel to execute the Quality Control function.

Job Qualifications: Individuals for this position should have a BS degree (preferably in Microbiology) with four years experience in manufacturing environment.  A MBA, while not required, is a plus.  Experience should be Quality related, management or Quality Engineering experience in an ISO and FDA regulated manufacturing environment.  They should have a strong, working knowledge of statistics and inspection practices and equipment.  Process strong organizational skills, capable of multitasking and tracking individual progress.  Have the ability to effectively communicate requirements, department status, task progress and procedural and process concepts, both orally and in writing.  Possess excellent interpersonal skills, able to represent company, departmental and customers interests in a multifunctional environment, providing guidance and conflict resolution.  Must have a working knowledge of ISO and FDA material and process controls and validations requirements.  Candidate should be familiar with Microsoft Word, Lotus Notes, Powerpoint and Excel databases.

Full-time

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