Description: **Candidates must live within 30 miles of the Client’s site in Holly Springs, NC.***
Job Details: The role will support the inspection, sampling, and testing of raw materials that are received at the Client North Carolina (ANC) site. This role will ensure that raw materials received for use in our cGMP manufacturing plants meet all specification requirements and master inspections characteristics required for use in our manufacturing process. This role will also demonstrate leadership skills in support of scheduling, coordination, and staff training. There will be opportunities to advance Quality learning through additional responsibilities and training.
Primary Responsibilities of the Role Include: • Inspect materials including biobags, tubing, filters, and other components to ensure all inspection-related specification requirements and master inspections characteristics are met • Remove samples from containers of medias and other chemicals to facilitate the testing of samples • Use RAMAN technology with TruScan equipment to identify chemicals • Ensure that inspection & sampling results are complete and detailed according to written procedures and cGMP requirements • Responsible for accurately documenting inspection, sample, and test results in Client’s systems • Responsible for ensuring that characteristics that could potentially impact product quality are assessed according to procedures • Ability to determine the color of components match required attributes • Support inspection readiness activities • Supports Continual Improvement initiatives, programs and projects • Assist area management with the prioritization and scheduling of tasks • Serve as a trainer in tasks associated with raw material inspections, samples, and testing • Own controlled documents for the area including SOPs and FORMs • Initiate and own deviation records and CAPAs associated with events and projects in ANC’s raw material inspections, samples, and testing areas • Provide QA oversight to Warehouse and ensure they are adhering to GMP regulations.
Top 3 Must Have Skill Sets:
Strong understanding of cGMP regulations and GDP requirements and experience with SAP, LIMS and Trackwise.
Experience with RAMAN technology, TruScan, and drafting and creating an SOP.
Experience in raw material inspections, sampling, and testing
A minimum of 1+ years of relevant working experience required.
Day to Day Responsibilities: Inspect materials including biobags, tubing, filters, and other components to ensure all inspection-related specification requirements and master inspections characteristics are met • Remove samples from containers of medias and other chemicals to facilitate the testing of samples • Use RAMAN technology with TruScan equipment to identify chemicals Ability to determine the color of components match required attributes • Assist area management with the prioritization and scheduling of tasks • Provide QA oversight to Warehouse and ensure they are adhering to GMP regulations.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
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: $26.56/hr.
