Job Description
Jobs › Northborough, MA › Compliance Specialist II 1st Shift Adecco US, Inc. Compliance Specialist II 1st Shift Northborough, MA Apply Adecco Healthcare & Life Sciences Research Associate II - Quality & GMP Compliance Fully Onsite |
Full-Time Pay:
35- 46/hr DOE Position Summary The Research Associate II is responsible for supporting quality assurance and compliance activities within a GMP-regulated manufacturing and laboratory environment. This role focuses on finished product inspection, retention sample management, quality systems support, and cross-functional collaboration with production and quality teams to ensure adherence to regulatory and internal standards. The position plays a key role in maintaining product quality throughout the lifecycle, supporting audits and inspections, and driving continuous improvement and compliance excellence. Key Responsibilities GMP Compliance & Quality Operations Ensure all activities are conducted in compliance with GMP and applicable regulatory requirements Perform finished product inspections according to established standards, specifications, and timelines Conduct AQL (Acceptable Quality Limit) inspections and ensure timely completion of quality checks Trend and analyze AQL failures in accordance with defined procedures and reporting requirements Support batch release activities ensuring compliance with GMP guidelines Sample & Retention Material Management Manage sampling, storage, monitoring, and maintenance of finished product retention samples Perform annual inspections of retention samples according to defined procedures Ensure proper documentation and traceability of all retention sample activities Quality Systems & Documentation Support creation, revision, and periodic review of product and material specifications Perform document control activities including creation, revision, and archival of quality documentation Support Quality Management System processes including Change Control, Deviations, and CAPA investigations Investigation & Continuous Improvement Support root cause analysis investigations for quality incidents and assist in implementing corrective and preventive actions (CAPA) Identify discrepancies and escalate quality-related issues in a timely manner Support risk management initiatives to prevent recurrence of quality issues Contribute to continuous improvement initiatives and quality performance enhancements Audit & Cross-Functional Support Participate in internal and external audits and regulatory inspections Provide documentation and subject matter support during inspections Collaborate closely with production teams to ensure adherence to quality standards on the shop floor Communicate quality findings, corrective actions, and performance metrics to relevant stakeholders Support quality walkthroughs and compliance reviews Required Qualifications Bachelor's degree required Minimum of 3 years of experience in quality assurance, GMP manufacturing, laboratory operations, or regulated industry environment Strong understanding of GMP principles and regulatory compliance requirements Experience with quality systems such as Change Control, CAPA, and Deviations Ability to perform structured inspections, documentation, and trend analysis Strong attention to detail and ability to identify and escalate compliance issues Excellent communication skills for cross-functional collaboration Ability to work independently in a fast-paced, regulated manufacturing environment Core Competencies Strong commitment to quality and regulatory compliance Analytical thinking and problem-solving ability High attention to detail and documentation accuracy Proactive escalation and risk identification mindset Ability to work in cross-functional production and quality environments Continuous improvement mindset and accountability for outcomes Strong communication and stakeholder coordination skills Work Environment Fully onsite role within GMP-regulated manufacturing/quality environment Frequent interaction with production floor and quality systems Active participation in inspections, audits, and compliance reviews Pay Details:
$34.00 to $46.00 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to apply To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.adecco.com/en-us/candidate-privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Active Filters Compliance Specialist II 1st Shift Northborough, MA Clear All Apply
