Compliance Specialist II (Manufacturing/Quality) 1st ...

Immediate need for a talented Compliance Specialist II (Manufacturing/Quality) 1st Shift. This is a 12+months contract opportunity with long-term potential and is located in Northborough, MA (Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID: 25-58463Pay Range: $35 - $46/hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).Key Responsibilities: Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.This position is responsible for performing a variety of complex tasks working independently with little to no supervision and in compliance with cGMP's to support Label and Packaging operations, finished goods and raw material disposition.Performing finished product disposition in accordance with Client SOP's, in-house product specifications and market regulationsReviewing and approving validation protocols and change controlsAuthoring, revising and reviewing SOP's through Veeva SystemUtilizing Veeva to complete investigation of deviations, CAPAs and Change ControlsSupporting compliance walkthroughs, Participate in internal auditsParticipate in QA audit readiness program as well as assist and participate in external audits and regulatory inspectionsInterpreting complex, explicit documentation for new and current procedures and FDA enforcement actions/trendsCompleting analysis, identifying issues and providing recommendations for compliance improvementsCompleting Quality Events in VeevaDevelopment and training of new staff as neededParticipate in specialized projects both within Quality and cross-functionallyPerform all aspects of Quality Disposition as it pertains to release activities that will include, but not limited to the disposition of raw materials and final packaging/component lotsSupport additional areas of Quality Disposition including Rejected, Quality Hold and Non-Conforming MaterialsEffectively demonstrates an understanding of GMPs & how it applies to specific responsibilitiesMaintaining material master data in ERP systemFollowing accurate oral & written procedures in performing QA tasksStaying up-to-date on training of all proceduresRoutinely and safely handle high value product vials in various stages of packaging completionAdhering to Client's safety procedures and guidelinesKey Requirements and Technology Experience: Key skills; Quality Control, SAP, GMP, VEEVA Bachelor's in chemistry or biology highly preferred but open to a BA in other sciencesExperience with: SAP, GMP, industry experience in quality control/manufacturingVEEVAWork Experience: minimum 4-5 (academia or industry)HM is looking for a someone at a Senior LevelParticipate in Lean initiatives to improve Quality processesParticipate in the QA consistency meetings to support continuous improvement effortsSupport the QA on the floor initiatives which includes; attending daily capacity management and +QDCI meetings and assisting customers with resolution of issues in real timeEffectively interact on a cross functional basis providing QA support at the area level and escalate any issues to Management in a timely fashionEnsure that department goals are achieved and on time Quality product is released through execution of primary role in area of oversight (Batch Record Review, Deviation Management and/or Lot Disposition, etc.)Comply with the requirements of Client health and safety program.Our client is a leading Healthcare Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here

Created: 2025-02-12