Title: Senior Specialist Quality Assurance - Level III (Senior) Location: 100% Remote Duration: 12 Months with possibility of extension
Qualifications: • Education: BS/MS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) with minimum 5 years of relevant experience within Quality Systems, Quality Assurance, and Quality Control. • Previous experience within the pharmaceutical industry or Medical Devices Combination Products with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control. • Must have working knowledge of regulatory expectations for the manufacture and/or testing of pharmaceutical products and/or Medical Devices Combination Products, with experience in quality, manufacturing, process validation and/or process technology transfer processes. • Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills. • Experience with Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc.
Required Skills: • Must have ability to make assessment of technical reports (example: investigations, product release) and determine acceptability based on organizational requirements. • Must be able to handle multiple priorities at a time and immediately address urgent issues. • Solves complex problems; takes a new perspective using existing solutions. • Accountable for medium sized projects with minimal resource requirements, risk and/or complexity. • Works independently, receives minimal guidance. • Experience with administration and data entry of technical reports into internal databases. • Explains difficult issues and works to build alignment around a complex situation. • Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills. • Strong knowledge of External Manufacturing management, supply chain, and operations. • Communicates easily in English both verbally and in writing. • Lean Six Sigma Systems training is an advantage. • Fluent in English language (reading, writing, and speaking)
Softwares: • Knowledge and competency with various IT systems, including Comet-SAP, Midas (document storage system), Track Wise Complaints system (QCC4), and Trackwise Change Control (GCM).
Responsibilities: Primary Activities may include, but are not limited to the following: • Evaluate and release products to other sites with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations. • Manage routine and complex deviations and complaints and assist in the coordination of significant investigations; assist in the coordination of report closures required by the external manufacturer. • Support routine and complex change requests and support process modification change controls. • Provide guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements. • Track and monitor operational and quality performance of the external manufacturer and work with supplier to develop CAPA plans, as needed. • Gather, interpret, and report, in a timely manner data for internal Annual Product Review (when required). • Participate with site visits to build relationships and monitor efforts to improve the external manufacturer’s quality and reliability through ongoing oversight and formal communication programs and forums. • Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as Subject Matter Expert (SME) Comments/Special Instructions
Note: If you are using AgileOne Resume format to submit your candidates, please make sure you remove this line from the resume and submit: "Merck previous experience: (contract/FTE)". Organon and Merck are both different clients, they are not part of each other since 2019. Key skills: • Complaint investigation experience within the medical device. • Medical device industry or medical device experience within pharmaceutical industry or Medical Devices Combination Products. • Deviation management, investigations and CAPA. • Experience with complaint management system like TrackWise. • Experience in regulated environment.
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: $40.00/hr.
