Quality Control Associate Bioanalytical Laboratory

TL;DR

Quality Control Associate (Bioanalytical Laboratory): Provides support to BAL staff for GLP/GCLP sample testing studies, performing QC review of study data, reports, logs, and documentation for accuracy and protocol adherence. Focus on identifying errors/deviations, collaborating with lab personnel to resolve issues, and participating in OOS investigations and study meetings.

Location: Gaithersburg, Maryland, USA (onsite office/lab environment)

Salary: $45,500 - $66,000 annually

Company

hirify.global is a biotechnology company offering bioanalytical laboratory services under GLP/GCLP standards.

What you will do

• Perform QC review of study data, reports, logs, equipment records, and documentation to identify errors and deviations.
• Communicate with BPIs, study coordinators, and lab personnel to resolve issues timely and keep detailed records.
• Escalate unresolved issues to managers and participate in reviewing OOS results and investigations.
• Execute study activities per SOPs, GLP/GCLP, GDP, and statements of work.
• Join study-related meetings as required.

Requirements

• Associate’s degree in biology, chemistry, or related field (Bachelor’s preferred)
• Minimum 1 year experience in bioanalytical QC or sample testing in GLP/GCLP environment (CRO experience highly preferred)
• Exceptional attention to detail, organizational skills, ability to multitask and meet deadlines.
• Basic understanding of PK, ADA, NAb, serology, and biomarker assays; knowledge of GDP (ALCOA+).
• Strong communication skills; proficiency in MS Office and SharePoint.
• Ability to work in office with periodic lab access; US work authorization (E-Verify)

Nice to have

• Experience reviewing large, complex bioanalytical data packages.
• Exposure to ligand-binding assays (ELISA, MSD) platforms.

Culture & Benefits

• Comprehensive medical, dental, vision, prescription coverage.
• 401(k) with company match, FSAs, short/long-term disability, group life insurance.
• Paid vacation, sick leave, holidays, parental leave; employee assistance program.
• Voluntary perks: fitness membership, pet insurance, identity theft protection, insurance discounts.
• Discretionary/non-discretionary bonuses based on performance and company success.