Kelly Services Quality Engineer in Parsippany, New Jersey
Location: Parsippany , New Jersey
Pay: 43 an hour
This position is to support business reorganization project as the key quality contact. This position is responsible for ensuring that the project maintains compliance and documents all activities as required by applicable FDA cGMP regulations as well as RB procedures and standards. The employee must be able to partner internally within quality organization to drive all quality priorities with the project team. This employee must be able to self-manage and work effectively with internal parties, manufacturing sites, and corporate personnel with minimal direct oversight. Oversee Quality and GMP related aspects of the project and qualification activities.
DUTIES & RESPONSIBILITIES
List a series of brief statements describing the end result or major activities of this position. Emphasize the end results rather than individual tasks or steps taken. List in order of their importance.
Function as the quality lead on project team.
Write SOPs, and help create new QMS system for Health and Hygiene Home Organizations
Interpret GMP regulatory requirements and provide guidance for effective compliance.
Lead the development of comprehensive documentation for the project and processes including change controls, deviations etc.
Lead the development of comprehensive quality strategies with the larger quality group
Provide support and guidance to teams in design control, process validation and process CTQ attributes.
Review and approve change controls, artwork, etc
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The incumbent may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
SKILLS & ABILITIES
Identify the specific kinds of knowledge and skills required to carry out the duties of this position in terms of format education specialized training, or prior experience or a combination. Identify the minimal requirements for the position rather than the personal qualifications of the incumbent(s). This might include listing positions, which are prerequisites for this position.
A minimum of a Bachelor’s degree in Engineering, Statistics, Chemistry, or Science related field is required.
A minimum of 4+ years of related work experience in a highly regulated industry is required. Medical Device, Biopharmaceutical, Pharmaceutical or other highly regulated industry
Experience in Good Manufacturing Practices required
Experience working in FDA regulated environment required.
Must exhibit excellent communication and facilitation skills, both oral and written.
Demonstrated ability to work independently and handle projects in a fast paced environment.
Ability to deal confidently and effectively with internal and external customers at all levels of the organization.
Demonstrated ability to manage/lead Quality deliverables within projects having more than one task is required.
Demonstrated ability to problem solve and collaborate effectively in matrix project team setting is required.
Ability to provide guidance and direction to teams to ensure compliance to regulatory (e.g., cGMP, FDA, QSR, ISO standards, etc.) and company procedures is required.
Experience collaborating and communicating quality requirements to external suppliers is strongly preferred.
Ability to effectively prepare and evaluate technical documentation for adequate compliance is required.
Why Kelly ® ?
Kelly puts you in charge of your career, with access to cutting edge projects and technologies in industry leading organizations. Top companies throughout the world have trusted Kelly as a premier source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety and flexibility of working on short term project engagements, or prefer contract-to-hire or direct hire placement with our clients, apply with Kelly to explore opportunities that suit your specific professional interests.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm