Quality Assurance Specialist

Proclinical is currently recruiting for a Quality Assurance Specialist with a pharmaceutical company located in Boston, MA.

Job Responsibilities:

• Serve as Quality Assurance support and SME for Drug Substance, Drug Product and Finished product manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant
• Providing oversight of GMP systems completed by CMO's and External Supply Chain function related to Drug Substance, Drug Product and Finished Product.
• Works closely to build relationships with contract manufacturers quality personnel.
• Responsible for reviewing contractor documents i.e. protocols, batch records, deviations and change controls
• Responsible for Product release activities.
• Approve specific standard operating procedures and controlled documents issued by contract manufacturing organizations.
• Support contract manufacturing organization audits, including pre-approval inspections
• Develop and issue quality metrics pertaining to the process quality activities.
• Trends and analyses quality aspects of technical transfer activities to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation, compiles and presents analyses at Quarterly Management Review meetings, proposes and leads team implementation of appropriate CAPA
• Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
• Review Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness
• Supports Quality Assurance to guide various projects and technical meetings, as needed.

Skills and Requirements:

• Must have experience/knowledge of drug substance/product/finished product manufacturing processes in a cGMP environment
• Must have knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing. Minimum of 5 years GMP related experience in biopharmaceutical / pharmaceutical or related industry
  Experience working with contract manufacturing organizations
• Ability to provide project leadership and guide successful completion of Quality projects
• Excellent written and verbal communication and negotiating skills

If you are having difficulty in applying or if you have any questions, please contact Bri Copeland at 267-297-3280.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-BC1