Compliance Specialist II (Manufacturing/Quality)

Immediate need for a talented Compliance Specialist II (Manufacturing/Quality). This is a 12 Months contract opportunity with long-term potential and is located in Northborough, MA , USA(Onsite). Please review the job description below and contact me ASAP if you are interested.Job Diva ID: 26-08294Pay Range: $33 - $43/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: Support department Quality Management System (Change Control, Deviations, CAPA)Main Accountabilities- Ensuring that activities within scope are conducted in compliance with applicable regulatory requirementsEnsuring compliance with Good Manufacturing Practices (GMP) and other relevant regulationsPerform finished product inspections according to standards, specifications established timelinesPerform AQL inspections according to standards, specifications established timelinesTrend AQL failures according to standards, specifications established timelinesEnsuring all batch release activities comply with Good Manufacturing Practices (GMP)Manage the sampling, storing, monitoring and maintenance of finished product retention samples according to standards, specifications and established procedures and timelinesManage / perform annual inspection of retention samplesSupport creation of new material and product specificationsPerform document creation/revision, including periodic reviews, for department documentation according to established procedures and scheduled timelinesSupport department Quality Management System (Change Control, Deviations, CAPA)Support department documentation archival systemCollaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloorManaging / escalating and resolving quality-related issues in a timely and effective mannerSupport the monitoring and analyzing of quality performance metrics, implementing corrective actions as neededSupport root cause analysis investigations for quality incidents and implementing preventive measuresSupport quality walkthroughsParticipating in internal and external audits and regulatory inspections providing support and documentation, as well as speaking as a subject matter expert in area of focusSupport risk management strategies to mitigate potential quality issuesFostering a culture of quality and continuous improvement across the organizationRequest corrections when GMP rules are not respectedPrioritize quality and compliance objectivesRequest quality improvement initiatives and strategiesIdentify discrepancies and corrective/preventive actions that need to be takenEscalate to upper management any failure in GMP execution on shopfloorInform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measuresAdvise on how to present a topic and answer specific questionsAdvise on risk management strategies and plansAdvise on initiatives to promote a quality-focused cultureKey Requirements and Technology Experience: Key skills: - Experience with inspecting finished goods and productQuality Shop floor experienceFully onsite position Possibility of extension Open to candidates willing to relocate at their own expenseTop candidates, references will be requested Free parking onsiteBachelors degree (Masters and PHD's will be accepted)3 Year experience in related role (more experience the better)Quality Shop floor experience, quality assurance review experienceExperience with inspecting finished goods and productPrevious pharma and biotech experience / GMP (strongly preferred)Change Control, Deviations, CAPA (strongly preferred) • SAP, VeevaMinimum 3 years of related experienceMinimum Education: Bachelors degreeOur client is a leading Pharmaceuticals 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 considerationPyramid 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, colour, 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