Job Title: Analytical Scientist Location: Social Circle, GA 30025 Duration: 12 months
Description: Expertise and technical leadership managing instrument/method validations change requests and improvement initiatives. Lead/Manage assay qualification and validation activities for QC, including authoring and/or reviewing protocols, coordinating testing with the functional area managers, performing statistical data analysis and final summary reports per ICH and internal guidelines. Lead investigator providing technical and analytical representation for, with strong understanding of compliance and cGMP's, strong scientific judgment and leadership in decision making. Coordinate analytical support within QC necessary to identify root cause. Facilitate major investigations, review of change control requests, provide representation to tech transfer as needed, review of process and method validation initiatives in support of the QC laboratories in the. Provide technical expertise and support for monitoring/assessing analytical method performance, troubleshooting and assay remediation. Manage and contribute to cross functional teams to Lead management of the document change requests for method SOPs. Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Acts as advisor to subordinates to meet schedules and/or resolve technical problems. Supporting regulatory activities including, but not limited to regulatory inspections and filings related to general analytical methodologies.
Responsibilities: Project Management (5%) Technical writing-author and review of protocols, reports, data summaries, procedures, etc (25%) Lead analytical method qualification and validation studies (400%) Support with Training personnel as required (10%)Work with QC, QA, Supply Chain, Analytical Development, Process Development, Manufacturing, Manufacturing Technical Service, Regulatory Affairs, and CMOs (10%).
Education and Experience Requirements: 7-10 year experience in pharmaceutical industries with focus on Chromatography/Mass-spectrometry and similar analytical instrumentation; Team leadership. Experience with analytical method validation and/or GMP investigations. Direct experience in authoring and review of CMC sections for regulatory filings. Direct experience in presenting CMC topics in regulatory inspections. Degree in Chemistry or Biological sciences.
Key Skills, Abilities, and Competencies: Direct experience within GMP organizations, experience in Quality preferred. Excellent, professional interpersonal and communication skills (both verbal and written). Demonstrated ability to work effective by independently and on cross functional teams. Internal and External Contacts: Internal: QC Biological & Analytical Sciences, Quality Assurance, Validation Vendor: Waters Customer: Analytical Development, Process Development, Manufacturing, Supply Chain.
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. 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: $60.00/hr.
