Facilities Engineering - Compliance Specialist
Facilities Engineering - Compliance Specialist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDAregulated industry. As a world leader in life science engineering and technical solutions MTG has the knowledge and experience to ensure compliance with pharmaceutical biotechnology and medical device safety and efficacy guidelines. With offices in Caguas PR Boston MA & San Francisco CA and we serve life sciences clients in six global markets: United States Puerto Rico Dominican Republic Mexico Germany Canada and South America.
Essential Functions:
- Leadership o Work collaboratively with site management to instill a Quality Culture by coaching in the application of GMP Principles including the underlying rational of those principles.
- Compliance Delivery o Support to the organization in conducting internal audits and hosting audits/inspections.
- New Business Growth o Work with Quality management to ensure quality systems support cGMP manufacturing of preclinical to commercial products.
- Compliance o Support the external and internal Audit Programs to be in an acceptable state of compliance.
- Responsible for audit preparations conducting internal audits and assisting client audits with site documentation gathering.
- Support Global Supplier Assurance work with the global team to participate and represent Texas Site in supporting joint audits.
- Ensure no overdue training. Support other QA teams and other functions in completion of site actions.
- All other duties as assigned.
- Excellent written and oral communication skills.
- Excellent organizational analytical data review and report writing skills.
- Ability to set personal performance goals and provide input to departmental objectives.
- Ability to multitask and easily prioritize work.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the employee is regularly required to:
- Experience prolonged standing some bending stooping and stretching.
- Ability to sit for long periods to work on a computer.
- Potential for exposure to chemicals gases fumes odors dusts and other hazardous materials.
- Ability to wear personal protective equipment including but not limited to safety glasses lab coat gloves specialized clothing including laboratory scrubs (pants and shirt) cleanroom (ISO 8 to ISO 5 gowning material and appropriate shoes required in most areas associated with this position.
- Lifting up to 25 pounds on occasion.
- Use handeye coordination and manual dexterity sufficient to operate a keyboard photocopier telephone calculator and other office equipment is required.
- Must be willing to work flexible hours.
- Ability to work weekends and offshift hours as needed to support manufacturing activities.
- Must be willing to travel occasionally as needed.
- Attendance is mandatory
- High School or equivalent: Seven 7 years or more of Pharmaceutical or other Regulated Industry experience.
- Associates Degree: Three 3 years or more of Pharmaceutical or other Regulated Industry experience.
- Bachelors Degree.
- Some exposure to good documentation practices cGMP/GLP regulations.
- Knowledge of GMP/GLP regulations
- Degree in Biology Chemistry or Engineering
Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirn consideracin para el empleo sin importar raza color religin sexo orientacin sexual identidad de gnero informacin gentica origen nacional estado de veterano protegido estado de discapacidad o cualquier otro grupo protegido por ley.
Mentor Technical Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity genetic information national origin protected veteran status disability status or any other characteristic protected by law.
Required Experience:
Senior IC
Employment Type
Contract
