Summary: Management of the GMP quality assurance oversight of Qualification, Validation, in relation to Facility Equipment, Computerized Systems, Laboratory systems in order to meet company's and regulatory requirements in Millburn, NJ.
Description: • Overall duties: o Represents site QA Validation SPOC (Single Point of Contact) for Facility Equipment and systems, Computerized Systems, Laboratory systems and participate on SOP authoring/review and implementation to site. Approves Validation strategy and plans for the site. o Act as SME (Subject Matter Experts) to develop validation and qualification procedures, train and guide site personnel in validation area including guidance on audit preparations or leading investigations whenever required. o Support establishment, review and approve maintenance plans and calibration strategy, and execution in collaboration with site Engineering function. o Review of deviations / non-conformances and lead the strategic discussion for investigations with respect to operations or validation related matters. o Review/approve investigation of operations in manufacturing/laboratory or other related operations. Oversee resolution of quality events, monitor that recurrent events are properly escalated and resolved. Ensure root cause is determined, evaluate impact on product quality, disposition and corrective actions. o Review and approve changes related to facility, computerized systems, laboratory or products. Ensure proper assessment with respect to Qualification and Validation is conducted. Performs QA oversight for Validation and Qualifications activities for Manufacturing, QC studies. o Contribute to the generation of the Annual Product Reviews. o Primary SME for the GMP regulatory inspections, specifically for qualification and validation matters. o Ensure the coaching and training of the quality team and other associates within the Production and QC in qualification and validation field.
• Successful and timely completion of Qualification and Validation activities. • Ensures investigations, CAPAs are completed in a timely /compliant manner. • No critical observation from Health Authorities and Corporate auditing.
Education MSc in Life Sciences and/or related experience
Skills and experience required: Bachelor's degree preferred - 5 years of experience in Pharmaceutical Manufacturing, at least 3 years combined of relevant experience in QA Validation role. - Proven track record and practical experience in establishing and maintaining quality systems, in facility changes and validation as well as successfully managing authority inspections from major HA’s. - In-depth knowledge of cGMP's, especially FDA regulations 21 CFR Parts 11 for computerized systems - Strong organizational and time management skills. - Quality oriented with attention to details. - Highly proactive, self-motivated, professional and dedicated.
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: $48.00/hr.
