Lead GLP QA Specialist job in Gaithersburg, USA

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

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Job type: Permanent

Discipline: Senior/Director & VP, Good Laboratory Practice (GLP)

Location: United States

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

Lead GLP QA Specialist - Permanent - Gaithersburg, MD

Proclinical is seeking a proactive, reliable, and experienced Quality Assurance Specialist with a strong background in Good Laboratory Practice (GLP). This is a permanent position based in Gaithersburg, MD.

Primary Responsibilities:

The successful candidate will play a crucial role in ensuring our operations and services meet the highest quality standards, contributing to the long-term success of our business. This role is perfect for an organized, flexible, and competent professional who excels in both quality assurance and quality control.

Skills & Requirements:

Bachelor of Science degree in Quality Assurance, Business Administration, or another undergrad degree focusing on safety & reliability, manufacturing, technical communications, statistics, and engineering or equivalent experience.
Experience in quality inspection, auditing, and/or testing.
Trained in Good Laboratory Practice (GLP) procedures.
SQA RQAP-GLP Certification is highly desirable.
Knowledge of College of Anatomic Pathology (CAP) credentialing requirements is a plus.
Knowledge of methodologies of quality assurance and standards.
Excellent communication and organizational skills.

The Lead GLP QA Specialist will:

Monitor studies to ensure facilities, equipment, personnel, methods, practices, records, and controls conform to GLP and CAP regulations.
Perform phase inspections, review maintenance records of equipment, and training records of laboratory staff.
Ensure compliance with all CFR Part 58 maintenance of records and indexing of the records.
Maintain a copy of all study protocols and the Master Schedule of all nonclinical laboratory studies.
Inspect nonclinical laboratory studies at adequate intervals to assure the integrity of studies and maintain written records.
Ensure no deviations from approved protocols or standard operating procedures are made without proper authorization and documentation.
Review final study reports to ensure they accurately describe the methods used, the SOPs followed, and raw data.
Prepare and sign the quality assurance statement included in the final study report.
Provide staff annual GLP training.
Responsible for the review and revision process of Standard Operating Procedures (SOPs).

If you are having difficulty in applying or if you have any questions, please contact Christina Chung at (+1) 857-233-9215 or c.chung@proclinical.com.

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.

INDCQA