Quality Systems Specialist
Spectraforce
North Chicago, Illinois
22 days ago
Job Description
Job Title: Quality Systems Specialist
Location: North Chicago, Illinois 60085
Duration: 12 Months
Description: 100% Onsite - hybrid can be negotiated in the future based on performance
Normal first shift working hours: 8 am to 4:30 pm. There is opportunity for some flexibility.
NOTE: While training, the candidate may be asked to begin the day no later than 7:00 am, as training will be provided by someone in Ireland’s time zone. This will improve availability of trainer/trainee to meet. Also- training will be onsite.
Purpose:
The candidate is responsible for providing quality assurance support for some or all parts of the Supplier Controls Quality System. Specific areas of support include Supplier Change Notification assessment, initiation of change control/change plan activities, and request/collection of feedback from manufacturing sites and affiliates. The person will ensure compliance to the quality system as it pertains to Supplier Change Notifications.
Responsibilities
Monitor global Supplier Change Notification inbox for change notifications
Evaluate Change Notifications to determine impacted materials and manufacturing sites using SAP, GTW, SolTRAQs, OneTrack
Initiate Change records to drive change management
Support collection of information and feedback across manufacturing sites and affiliates.
Required Skills:
4+ years’ experience. Bachelor’s Degree in a Science or Engineering field. Master’s preferred but not required.
Experience in quality systems e.g., change controls, supplier management, deviations, documentation, CAPA, audits, experience with supplier change notifications, searching vendors in SAP, Soltraqs/Trackwise experience.
Experience in a Regulatory Pharmaceutical Industry.
Experience in managing and finding resolutions from complex situations or that are not well-defined, in a timely fashion.
Skills: Excellent written and oral communication skills, detail oriented, adaptable, flexible, organized, time management skills, problem-solving skills, works well independently and cross- functionally in a fast-paced industry environment.
English is the first language
Experience in Quality, Change Control, CAPA, Operations, Documentation
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $31.00/hr.
Location: North Chicago, Illinois 60085
Duration: 12 Months
Description: 100% Onsite - hybrid can be negotiated in the future based on performance
Normal first shift working hours: 8 am to 4:30 pm. There is opportunity for some flexibility.
NOTE: While training, the candidate may be asked to begin the day no later than 7:00 am, as training will be provided by someone in Ireland’s time zone. This will improve availability of trainer/trainee to meet. Also- training will be onsite.
Purpose:
The candidate is responsible for providing quality assurance support for some or all parts of the Supplier Controls Quality System. Specific areas of support include Supplier Change Notification assessment, initiation of change control/change plan activities, and request/collection of feedback from manufacturing sites and affiliates. The person will ensure compliance to the quality system as it pertains to Supplier Change Notifications.
Responsibilities
Monitor global Supplier Change Notification inbox for change notifications
Evaluate Change Notifications to determine impacted materials and manufacturing sites using SAP, GTW, SolTRAQs, OneTrack
Initiate Change records to drive change management
Support collection of information and feedback across manufacturing sites and affiliates.
Required Skills:
4+ years’ experience. Bachelor’s Degree in a Science or Engineering field. Master’s preferred but not required.
Experience in quality systems e.g., change controls, supplier management, deviations, documentation, CAPA, audits, experience with supplier change notifications, searching vendors in SAP, Soltraqs/Trackwise experience.
Experience in a Regulatory Pharmaceutical Industry.
Experience in managing and finding resolutions from complex situations or that are not well-defined, in a timely fashion.
Skills: Excellent written and oral communication skills, detail oriented, adaptable, flexible, organized, time management skills, problem-solving skills, works well independently and cross- functionally in a fast-paced industry environment.
English is the first language
Experience in Quality, Change Control, CAPA, Operations, Documentation
About Us: SPECTRAFORCE is one of the fastest-growing workforce solutions firms in the United States. As a diversity-owned business, we place human connection at the heart of everything we do, building strong relationships with both clients and candidates to fill roles successfully. Our teams in North and Central America and India serve more than 150 Fortune clients globally, leveraging custom AI technology to provide direct hire, executive search, nearshoring, offshoring, and project staffing solutions.
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $31.00/hr.