Note: Hybrid role with up to 80% onsite support. Onsite schedule will be as needed.
Three roles - the team is looking for three different specialties
1) Analytical validation & method
2) Both analytical validation & method experience and writing quality risk assessments (QRA's) for lab sample chain of custody.
3) Strong background in sample, stability, and reserve management. This person is going to assist in implementing the processes in place for the new site.
Ideally the candidate will have extensive diversified experience in commissioning of Quality Control (QC) Equipment supporting all QC laboratories, (Chemistry, Bioassay, Raw Material, and Microbiology). The candidate must have at least 15 years of functional experience and capable of leading technical documentation supporting Analytical Method Validation/Verification required to support GMP QC Laboratory readiness activities at the client North Carolina facility. • Extensive experience designing/writing protocols/reports for Method Validations, Verifications, Transfers, Material Qualifications, and Stability studies. • Core Analytical Competencies must include, but not limited to, HPLC/UPLC, HPIC, SEC (UV, CAD, ELSD, Fluorescence, Conductivity)K-F, TOC, ELISA, cell based assays, peptide mapping, glycan, aggregate and excipient analysis, and sample preparation techniques. • Create strong technically sound Standard Operating Procedures (SOPs), Operation and Maintenance (O&M) Procedures, Equipment Data Integrity Assessments, etc. required to support QC Laboratory Startup • Process document changes within the electronic Quality Management System (eQMS) while ensuring good documentation practices (GDP) • Manage document lifecycle updates to support QC Laboratory Readiness metric reporting • Author Analytical Equipment Qualification Protocols (Performance Qualification Protocols) and Compendial Verifications to support ANC QC Laboratory Readiness as necessary • Provide validation and change management support for Laboratory Equipment/Method Readiness. • Lead QC Quality Risk Assessments for Sample Chain of Custody and Analytical Testing • Provide incident management support associated with nonconformances • Identify technical/operational gaps and propose solutions.
Job Details: Develops, writes, edits, and formats materials such as Standard Operating Procedures, Business Practices, forms, checklists, technical manuals, installation guides, user manuals, and related technical protocols/reports and business process documentation. When creating, updating and enhancing the documentation, adhere to format, content and style guidelines, giving consideration to usability and ensuring accuracy, consistency and quality. Additionally, this position will be required to administer the processing of documents via the established Document Processing Review process. May require communication through a variety of media (e.g., CD, intranet, on-line training, etc.); Skills: ; MS Office expertise ; previous technical writing experience ; regulated environment experience ; document version control experience ; excellent communication/writing skills
Day to Day Responsibilities:
Working with each QC Laboratory (Chemistry, Bioassay, Raw Material, and Microbiology), to create the technical documentation supporting Analytical Method Validation/Verification/Quality Risk Assessments/Equipment Commissioning required to support GMP QC Laboratory readiness activities at the client North Carolina facility.
Top 3 Must Have Skills:
1. Extensive experience designing/writing protocols/reports for Method Validations, Verifications, Transfers, Material Qualifications, and Stability studies.
2. Experience leading QC Quality Risk Assessments for Sample Chain of Custody and Analytical Testing
3. Create strong technically sound Standard Operating Procedures (SOPs), Operation and Maintenance (O&M) Procedures, Equipment Data Integrity Assessments, etc. required to support QC Laboratory Startup
Basic Qualification
Doctorate Degree or Master Degree and 3 years of clinical experience or Bachelor Degree and 5 years of clinical experience or Associate degree and 10 years of clinical experience or high school diploma/GED and 12 years of clinical experience
Possible Extension: Yes
Red Flags:
No experience writing Analytical Method Validation/Verification Protocols/Reports
Less than 12+ years of relevant experience.
Interview Process: 1 video call with hiring manager.
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.
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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: $54.67/hr.