Compliance Specialist III

Immediate need for a talented Compliance Specialist III. This is a 11+months contract opportunity with long-term potential and is located in Framingham, MA(Hybrid). Please review the job description below and contact me ASAP if you are interested.
 
Job ID:25-56243
 
Pay Range: $50 - $52/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:

• Leads projects as assigned such as new product launch teams.
• Identify and leads the resolution of quality related issues that impact cGMP compliance, regulatory filings, or other risks, to client products.
• Collaborates with subcontractors to find and implement solutions concerning quality issues.
• Respond to customer complaints, including close out and determination of corrective actions by collaborating with CMO’s and identifying trends.
• Identify and prevent or resolve issues that could impact the continuity of supply of existing products.
• Review/Approve sub-contractor's validation protocols, Master Documents and significant deviations and investigations. Identify trends to reduce Quality anomalies.
• Constant contact with the Senior Director of Quality and Regulatory, EM- North America and Global Quality.

Key Requirements and Technology Experience:

• Key Skills:Batch record, Electronic Quality Management systems (Trackwise/Documentum/Veeva), GMP .
• Excellent oral and written communication skills in cGMP documentation.
• Experience in 3rd party manufacturing Quality and Regulatory function and/or same plant experience
• Interpersonal skills to interface with suppliers and customer to develop privileged communications and relationship
• The incumbent should possess significant technical knowledge related to typical Quality Assurance activities in the pharmaceutical and medical device industries especially those related to handling product complaints and the associated regulations
• Understanding of various drug product manufacturing including oral dosages, semi-solids, liquids, injectables, lyophilized and medical drug/device combinations
• Project management skills .
• Bachelor of Science .
• 5-7 years in Pharmaceutical Operations or Quality Operations with the application of cGMPs in the Pharmaceutical or related regulated industry .

Our client is a leading Pharmaceutical 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, 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 .

#Mor 2 J2W:CB3