Quality Assurance Manager - 172475

Piper Companies; Elkridge (MD); On-site; USD 115,000 - 135,000; Full time

Benefits offered by this job

Comprehensive benefits package

Job summary

Piper Companies is seeking an experienced Quality Assurance Manager in Elkridge, MD, to lead a QA team in a GMP environment. You will ensure regulatory compliance, manage document control, and oversee eDMS administration.

The role requires 8+ years in FDA/GMP settings, deep cGMP knowledge, and a scientific degree. Onsite work with comprehensive benefits is provided. This position offers a competitive salary and growth opportunities in a growing pharmaceutical company.

Qualifications

• 8+ years in FDA/GMP manufacturing environments.
• Hands-on leadership in pharmaceutical QA.
• Deep knowledge of US/EU cGMP regulations.
• Bachelor’s or higher degree in a scientific field.

Responsibilities

• Oversee QA team in a GMP manufacturing setting.
• Maintain document control and change control processes.
• Administer the eDMS system and training workflows.
• Ensure regulatory compliance of documents.
• Review deviations, OOS, complaints and investigations.

Skills

Quality management

Leadership

Regulatory knowledge

Documentation control

GMP experience

Education

Bachelor’s degree in a scientific field

Tools

eDMS

Job description

Piper Companies is currently looking for an experienced Quality Assurance Manager in Elkridge, Maryland (MD) to work for an innovative and growing pharmaceutical company.

Responsibilities for the Quality Assurance Manager include:

• Manage a team of quality assurance professionals within a GDA/GMP Pharmaceutical manufacturing environment.
• Follow Policies and SOPs to support the document approval process, assign effective dates and training workflows, and archive documents and document change requests.
• Serves as the Electronic Document Management System (eDMS) administrator, maintains and implements eDMS processes; partners with Validation to manage/maintain change control and validation documentation for eDMS.
• Coordinate with document originators and/or stakeholders to resolve document control issues to obtain final approval/ensure smooth operation of all functions.
• Manage the organization of controlled document files within the Document Control center and ensure that records are readily retrievable.
• Ensure all controlled documents follow regulatory requirements, including FDA and international guidelines.
• Maintain employee training records, document master files, authorized signature forms according to company procedures, industry best practices, and government regulations.
• Carry out a variety of activities to support manufacturing operations becoming familiar with site processes, procedures, and policies as individual develops knowledge aligned with cGMPs and Health Authority regulations.
• Review and approval of qualification activities, quality records like deviations OOS, complaints, auxiliary forms, investigations, procedures and other quality related documentation.

Qualifications for the Quality Assurance Manager Include:

• A minimum of 8+ years of work experience within FDA/GMP regulated manufacturing environments
• Hands on leadership experience within pharmaceutical quality assurance
• In-depth knowledge of cGMP and regulatory requirements (US and EU) applicable to the pharmaceutical, biotechnology, or related industries.
• Bachelor’s or higher degree within in Scientific field

Compensation for the Quality Assurance Manager include:

• Salary Range is $115,000 – $135,000 dependent upon experience
• Comprehensive benefits package

Keywords

Pharmaceutical Manufacturing, QA, Quality Assurance, Manager, Leadership, FDA, Science, comprehensive benefits package, Health, Vision, Dental #LI-ONSITE #LI-DF1