Quality Control Chemist

Advanced Clinical; Frederick (MD); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading clinical development organization is seeking a Quality Control Chemist in Frederick, Maryland. This role involves testing raw materials and final products, maintaining laboratory compliance, and contributing to quality control processes. Ideal candidates will have a relevant degree and experience in biotechnology. Join a dynamic team to impact the clinical industry positively.

Qualifications

• Bachelor's Degree or equivalent experience in biotechnology or related field.
• 2+ years experience in Quality Control for Associate's Degree holders.
• 3+ years experience for High School Diploma holders.

Responsibilities

• Perform testing of raw materials and final products using analytical methods.
• Monitor and trend data for in-process testing and product release.
• Author or revise SOPs and qualification/validation protocols.

Skills

GMP

SOPs

Quality Control Processes

Communication

Education

Bachelor's Degree

Associate's Degree

High School Diploma

Tools

MS Word

Excel

PowerPoint

Job description

Join to apply for the Quality Control Chemist role at Advanced Clinical.

Overview

We are currently searching for a skilled professional to join a well-known client’s team as a contract Quality Control Chemist in Frederick, Maryland. Their work will have a direct impact on the organization and the larger clinical industry, making this an exciting career opportunity.

Responsibilities

• Perform testing of raw materials, intermediates, and final products using analytical methods such as Cell-based bioassays, Flow Cytometry, ELISA, and qPCR assays.
• Collaborate with internal and external resources to maintain the lab in optimal condition.
• Monitor and trend data, review routine test data and related documents for in-process testing, drug substance, and drug product release. Support generation of CoAs for product release.
• Maintain laboratory instruments through calibration and routine maintenance.
• Author or revise SOPs, qualification/validation protocols, and reports.
• Assist with laboratory investigations regarding out-of-specification (OOS) results and determine root causes for deviations related to analytical procedures.
• Provide updates during daily and weekly meetings.
• Monitor GMP systems to ensure compliance with documented policies.

Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies as appropriate.

• Gather metrics for continuous improvement of responsibilities.
• Perform other duties as required.

Education & Experience

• Bachelor's Degree
• Associate's Degree with 2+ years of experience in biotechnology or related field and Quality Control experience
• High School Diploma with 3+ years of experience in biotechnology or related field and Quality Control experience

Required Skills and Strengths

• Strong knowledge of GMP, SOPs, and quality control processes
• Experience in identifying, writing, evaluating, and closing OOSs and investigations
• Proficiency in MS Word, Excel, PowerPoint, and other applications
• Strong communication skills, both written and verbal
• Ability to work independently with scientific/technical personnel
• Knowledge of analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays
• Working knowledge of quality systems and regulatory requirements (e.g., 21 CFR Part 11/210/211)

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization providing services including CRO, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition for pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. Our mission is to deliver a better clinical experience for clients and candidates. For more information, visit http://www.advancedclinical.com.

We carefully review every application and appreciate your patience during the process.