**This is a four month contract-to-hire position. Would be converted to a permanent employee after four months.
Summary of Essential Duties & Responsibilities:
● Perform analytical testing and ensure timely reporting of results in compliance with GMP
standards.
● Manage sample custody, QC analyst schedules, and real-time documentation during
tests.
● Author and review technical documents, and collaborate with AR&D, CMC, and
regulatory teams for filings (IND/BLA/MAA).
● Conduct laboratory investigations, perform root cause analysis, and ensure equipment
calibration/validation.
● Review analytical data, peer-review test results, and ensure compliance with cGMP and
company policies.
● Execute and transfer cell-based assays, operate microbiological/analytical instruments
(HPLC, GC, ICP-MS, etc.), and perform techniques like q-PCR and ELISA.
● Assist in purchasing lab equipment and handle internal calibrations.
● Review QC data, release testing data, and maintain quality records for regulatory
compliance.
● Train and assist junior QC associates and maintain quality metrics for stability testing.
● Update instrumental SOPs, initiate investigations (OOS/OOT), and ensure completion of
internal quality events.
● Collaborate with cross-functional teams for compliance with industry standards and
regulatory guidelines.
● Support internal/external audits and escalate operational risks to senior management.
● Manage and mentor direct reports, ensuring adherence to company policies and training
requirements.
Education:
● Master’s or Bachelor’s degree in Chemistry, Molecular Biology, Cell Biology, or a related
field.
Special Skills:
● Bachelor’s degree with 12+ years or M.S. with 8+ years of experience in QC or the
pharmaceutical/biopharmaceutical industry.
● Strong cGMP knowledge and industry experience required.
● Must have a positive attitude, team-oriented mindset, and leadership skills to resolve
issues and achieve organizational goals.
● Experience in multi-disciplinary project management, along with strong communication
and decision-making skills.
● Ability to work well under pressure and maintain inspection readiness for
internal/external audits.
● Knowledge of global GxP compliance and strong presentation skills.
● Excellent time management, organizational, analytical, and interpersonal skills.
● Self-motivated, adaptable, and effective in dynamic, problem-solving environments.
● Strong influencing, negotiation, and communication skills at all organizational levels.
● Proficient in Microsoft Word, PowerPoint, and Excel.
