Remote Quality Control Biotech Jobs in Portage, MI

Job Title: Associate Change Control & Data Retrieval Specialist Location: Portage, MI Type: Contract Compensation: $30-36/hr Work Model: Hybrid – onsite and remote

Responsibilities • Lead data retrieval and collection efforts across internal systems (e.g., PLM, ERP, QMS) and external sources (e.g., suppliers) to support PEC regulatory requirements (e.g., REACH, RoHS, PFAS, PPWR). • Compile, cleanse, and validate complex datasets to ensure accuracy, traceability, and readiness for regulatory submissions and internal reporting. • Partner cross-functionally (Engineering, Supply Chain, Regulatory, Quality, and external suppliers) to obtain required material, component, and product-level compliance data. • Create and manage Enterprise Change Notices (ECNs) within the Quality Management System to implement updates tied to PEC findings, ensuring all documentation and data inputs are compliant and audit-ready. • Translate regulatory requirements into data needs, identifying required attributes, documentation, and evidence to support compliance initiatives. • Support supplier engagement and outreach to request, track, and follow up on material declarations, certifications, and compliance documentation. • Perform data analysis and gap assessments, highlighting missing or inconsistent information and driving resolution with stakeholders. • Maintain and update project tracking tools and dashboards, ensuring visibility to data collection progress, risks, and completion status across PEC programs. • Contribute to process improvements by standardizing data collection methods, templates, and workflows to enhance efficiency and scalability of PEC efforts. • May act as Change Owner as needed, coordinating implementation plans and ensuring execution aligns with regulatory timelines.

Requirements • Bachelor’s degree in Engineering or related field • Strong attention to detail with the ability to manage and interpret complex datasets • Demonstrated ability to gather, analyze, and validate data from multiple sources • Excellent communication and collaboration skills across diverse, global teams • Strong organizational and project management capabilities • Experience in change control or change management within a regulated industry (Preferred) • Experience in the medical device industry (Preferred) • Familiarity with Product Environmental Compliance (PEC) regulations (e.g., REACH, RoHS, PFAS) (Preferred) • Experience with PLM tools (Windchill/onePLM) or similar systems (Preferred) • Experience working with supplier data collection and compliance documentation (Preferred)

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #558-Scientific