Johnson Service Group, is looking for a Quality Control Specialist for a biotech manufacturing company in Carlsbad, CA.
This is a direct hire opportunity | Onsite | The pay range for this position is between $75K - $90K depending on qualifications.
In this role you will perform analyses of in-process materials, finished products, and stability samples while supporting Environmental Monitoring (EM) and raw material inspections. Reporting to the Director of Quality Control, this role requires strict adherence to QC policies, cGMP standards, and a strong commitment to quality and safety.
Responsibilities:
- Raw Material Inspection: Conduct incoming inspections of raw materials following company policies and procedures.
- Environmental Monitoring (EM): Perform routine EM activities, including sampling of USP Purified Water systems and plant utilities.
- Sample Management: Expedite test sample shipments to sponsors and third-party laboratories.
- Deviation Management: Lead investigations into deviations and out-of-specification (OOS) results, and implement corrective and preventive actions (CAPAs) and change controls in alignment with GMP requirements.
- Method Transfers: Support analytical method transfers, including product-specific test methods.
- Laboratory Operations: Perform routine analyses of in-process, release, and stability test samples according to established QC methods and specifications.
- Safety Leadership: Act as a liaison with Environmental Health and Safety (EHS) teams and the Safety Officer.
- Calibration Support: Assist Quality Assurance (QA) in maintaining and calibrating lab instrumentation.
Qualifications and Experience:
- Education: Bachelor’s degree (B.A. or B.S.) in a Life Science discipline.
- Experience:
- 3-4 years of cGMP experience in Quality Control, preferably within the medical device or biopharmaceutical industries.
- Hands-on experience with EM sampling and aseptic techniques.
- Familiarity with analytical laboratory methods and instrumentation.
- Skills and Attributes:
- Exceptional attention to detail and precise documentation skills.
- Ability to thrive in a fast-paced, dynamic environment.
- Strong oral communication and active listening skills.
- High level of integrity, professionalism, and a strong work ethic.
- Capability to work independently with minimal supervision. For immediate consideration, please reach out to Foster Zembrawski fzembraski@jsginc.com
#D800
** Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.
