Sr. Quality Specialist job in Norristown, USA

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Good Manufacturing Practice (GMP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is currently recruiting for a Senior Quality Specialist for a pharmaceutical company located in Norristown, PA. Successful candidate will be responsible for supporting the Associate Director, Quality with the management of Quality System and Quality Assurance functions.

Job Responsibilities:

Author, review and approve Quality Management System documentation including: Deviation, CAPA, Customer Complaint, Change Control
Provide GMP, GDP and SOP training to employees
Perform Self-Inspections
Perform vendor qualification activities including review of audit questionnaires, performance of on-site audits
Author, review and approve Quality Agreements with Customers and Vendors
Participate in and/or host Customer Audits and Regulatory Inspections
Author, review and approve SOPs, Forms, and Specifications
Perform pre- and post- execution review and of secondary packaging and labeling batch records
Perform pre- and post- execution review of facility qualification documents
Participate in ERP implementation as QA Subject Matter Expert and serve as superuser post go-live
Report quality metrics to management
Participate in and/or lead Quality Management Reviews
Participate in and/or lead Risk Assessment and Mitigation activities
Liaise with all global QA Departments to harmonize processes
Lead and implement process improvement projects
Provide quality and regulatory support to other departments
Other activities as required

Requirements:

Bachelor's degree or equivalent experience. 5+ years of experience in pharmaceutical quality assurance.
Solid understanding of GMP, GDP and other applicable regulatory requirements and the ability to apply them to business scenarios
Skilled in MS Office (Outlook, Word, Excel, PowerPoint)
Ability to manage multiple responsibilities simultaneously and adapt to changing priorities
Results oriented, confident, self-motivated and driven with high energy
Good analytical abilities and problem-solving techniques

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kaye Dunleavy at (+1) 646-367-2646 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

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-KD1
#QualityAssurance

Related jobs

GMP QC Analyst

Salary

US$25 - US$30 per hour

Location:

Norton, USA

Proclinical is on the hunt for bold, innovative thinkers who are ready to help push the boundaries of science and make a tangible difference in the world.