Quality Control Analyst; QC Analyst

Immediate need for a talented Quality Control Analyst (QC Analyst). This is a 12+ Months Contract opportunity with long-term potential and is located in Fredrick, MD (Hybrid).

Job
-30216

Pay Range: $28 - $30/hour. Traveler benefits as per agency package. (Benefits vary by vendor and assignment.)

Key Responsibilities:

• Perform QC analytical testing of raw materials, intermediates, drug substances, and final drug products according to approved analytical methods and SOPs.
• Perform laboratory assays including Flow Cytometry, ELISA, qPCR/PCR, cell-based bioassays, and other applicable biopharmaceutical analytical methods.
• Review and trend laboratory data and complete routine review of test results and supporting documentation.
• Support in-process testing and drug substance/drug product release activities.
• Provide testing information and analytical data to support Certificate of Analysis (CoA) generation.
• Maintain laboratory instruments and equipment, including calibration, routine maintenance, and troubleshooting activities.
• Work with internal and external resources to maintain the laboratory in an optimal, compliant, and inspection-ready condition.
• Author, revise, and maintain SOPs, qualification/validation protocols, reports, and other controlled documents.
• Support laboratory investigations associated with Out-of-Specification (OOS) results.
• Participate in deviation investigations and assist with root-cause analysis related to analytical procedures.
• Ensure accurate and timely documentation of laboratory activities in accordance with GMP and data integrity requirements.
• Monitor applicable GMP quality systems and ensure compliance with established procedures and policies.
• Support review of proposed changes to laboratory systems, procedures, analytical methods, and related regulatory documentation.
• Gather and analyze laboratory metrics to support continuous improvement.
• Communicate testing status, laboratory activities, issues, and priorities during daily and weekly meetings.
• Collaborate effectively with Quality, Manufacturing, Analytical, Scientific, and Technical teams.
• Perform other QC laboratory duties as assigned.

Key Requirements and Technology

Experience:

• Bachelor's degree in Biology, Biochemistry, Chemistry, Biotechnology, Microbiology, or a related scientific field; OR
• Associate's degree + 2 years of experience in biotechnology or a related field with Quality Control experience; OR
• High School Diploma/GED + 3 years of experience in biotechnology or a related field with Quality Control experience.
• Experience working in a biotechnology, biopharmaceutical, pharmaceutical, or biologics laboratory.
• Hands-on experience in a GMP Quality Control environment.
• Strong understanding of GMP, SOPs, laboratory quality systems, and QC processes.
• Experience with OOS investigations, deviations, root-cause analysis, and investigation documentation.
• Hands-on experience with one or more of the following:
• Flow Cytometry / FACS
• ELISA
• qPCR / PCR
• Cell-based assays
• Other analytical methods used for biopharmaceutical testing
• Working knowledge of 21 CFR Part 11, 21 CFR Part 210, and 21 CFR Part 211.
• Experience with laboratory instrument calibration, maintenance, and troubleshooting.
• Experience writing or revising SOPs, protocols, validation/qualification documents, and technical reports.
• Strong understanding of laboratory documentation and data integrity requirements.
• Proficiency with Microsoft Word, Excel, PowerPoint, and other standard laboratory applications.
• Strong written and verbal communication skills.
• Ability to work independently while collaborating effectively with scientific and technical personnel.
• Strong attention to detail and ability to work effectively in a fast-paced, regulated environment.

Our client is a leading Pharmaceutical Industry and we are currently interviewing to fill this and other similar contract positions.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

By applying to our jobs you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply.…