Quality Control Analyst – Onsite

ApTask Global Workforce; Frederick (MD); On-site; USD 34,000 - 49,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Sick Pay

Job summary

Aptask Global Workforce (AGW) seeks a Quality Control Analyst for an onsite, 6+ month contract with a Global Biotechnology Company in Frederick, MD. Test raw materials, intermediates and final products in a GMP laboratory using Flow Cytometry, ELISA, qPCR and cell-based bioassays.

Training lasts 7 weeks (Mon-Fri, 7:30 AM-4:00 PM) followed by Wed-Sat shifts (7:00 AM-5:30 PM). Requirements include a Bachelor’s or AA with QC biotech experience, or HS with QC experience.

Qualifications

• Bachelor’s Degree OR AA with 2+ years QC experience in biotech.
• High School Degree with 3+ years QC experience.
• Quality control experience and GMP knowledge.
• Experience in investigations of OOS results.
• Proficient in MS Word, Excel, PowerPoint.
• Strong written and verbal communication.
• Experience with Flow Cytometry, ELISA, qPCR.

Responsibilities

• Test raw materials, intermediates, and final products using approved methods.
• Maintain lab in optimal state with internal/external resources.
• Review test data and documents for in-process testing and release.
• Provide information to support CoA generation.
• Maintain laboratory instruments and calibration.
• Write or revise SOPs and validation documents.
• Investigate OOS results and determine root cause.
• Provide updates at daily/weekly meetings.
• Monitor GMP systems for policy compliance.
• Review proposed changes to systems and methods for regulatory submissions.
• Gather metrics for continuous improvement.

Skills

GMP knowledge

OOS investigations

Analytical techniques

Communication skills

Independent work

Flow Cytometry

ELISA

qPCR

Cell-based assays

Biotech/pharma experience

Education

Bachelor’s Degree

AA Degree + 2+ years QC

High School Degree + 3+ years QC

Tools

MS Word

Excel

PowerPoint

Job description

Aptask Global Workforce (AGW) is seeking a Quality Control Analyst for an Onsite position with a Global Biotechnology Company located in Frederick, MD. This is a 6+ month contract opportunity.

This role involves performing testing of raw materials, intermediates, and final products within a GMP-compliant laboratory environment. The successful candidate will utilize analytical methods such as cell-based bioassays, Flow Cytometry, ELISA, and qPCR assays to ensure product quality and support release activities. For the first 7 weeks of the assignment, all contractors are required to work Monday-Friday from 7:30 AM to 4:00 PM to complete training; after training, the shift will be Wednesday to Saturday from 7:00 AM to 5:30 PM.

Responsibilities:

• Perform testing of raw materials, intermediates and final products by following analytical methods: Cell based bioassays, Flow Cytometry, ELISA and qPCR assays
• Work with internal and external resources to maintain lab in an optimal state
• Assist with monitoring and trending data, complete routine record review of test data and related documents for in-process testing, drug substance and drug product release
• Supply information to support generation of CoAs for product release
• Maintain laboratory instruments for calibration and routine maintenance
• Author or revise SOPs, qualification/validation protocols and reports
• Assist with lab investigations regarding out of specifications (OOS) results and participate in determination of root cause for deviations
• Provide updates at daily and weekly meetings
• Monitor the GMP systems currently in place to ensure compliance with documented policies
• Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate
• Gather metric information for use in continuous improvement of areas of responsibility

Requirements:

• Bachelor’s Degree OR
• AA Degree and 2+ years of experience in biotechnology or a related field and Quality Control experience OR
• High School Degree and 3+ years of experience in biotechnology or a related field and Quality Control experience

Desired skills:

• Strong knowledge of GMP, SOPs and quality control processes
• Experience identifying, writing, evaluating, and closing OOSs and investigations
• Proficient in MS Word, Excel, PowerPoint and other applications
• Strong written and verbal communication skills
• Ability to communicate and work independently with scientific/technical personnel
• Well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays
• Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211)
• Experience in the biotech and/or pharmaceutical industry

Pay range: up to $30.07 per hour

Aptask Global Workforce (AGW)

ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.