17008 QA Manager

TITLE:                    QA Manager

LOCATION:         Frederick, MD   

REQ#:                    17-008

Overview: Jecho Laboratories, Inc. (Jecho) is a biopharmaceutical company developing innovative therapeutic biologics, including therapeutic monoclonal antibodies, cytokines, immunotoxins, and vaccines to address a broad range of diseases as well as treatment of cancer and infectious disease. The company is in clinical development stage of a number of candidates.

Jecho is seeking a highly reliable and competent professional to join our QA team in Frederick, MD. Qualified individual will lead quality assurance activities whose approval will be necessary for the continuation of a business life cycle in the company. The candidate is expected to work partially in an affiliated company oversea.

Essential Job Functions:

  • Determine, negotiate and draft in-house quality policies, SOPs, standards and product specifications
  • Work with operating and testing staff to establish procedures, standards, systems and procedures
  • Assess customer requirements and ensuring that these are met
  • Specify quality requirements of raw materials with suppliers and executing vendor audits
  • Ensure that manufacturing processes comply with standards at both national and international level
  • Conduct internal or host customer quality audits, monitor and ensure the company wide quality, compliance, performance and documentation
  • Train and supervise technical or laboratory staff on general GXP compliance
  • Monitor facility, equipment calibration and validation program.
  • Maintain all GMP and key company documents per SOP procedures
  • Participate in QA activities in affiliated company oversea

Minimum Requirements:

  • MS in Biology, with more than 8 years experience in industrial filed
  • A working experience of GMP and QA is required.
  • Previous experience of technical writing, such as SOPs, qualification/validation protocol and reports, change control or deviation investigation etc, is required.
  • Excellent multi-task ability, good organizational skills, and team-oriented personality is a must.
  • Excellent written and oral communication skills.
  • A proven leadership skill is a plus.
  • Skillful on basic computer software including Excel, Word and Powerpoint.

Compensation:

Jecho offers a competitive salary and excellent benefits package.

Jecho is an equal opportunity employer.

Please submit resumes to This email address is being protected from spambots. You need JavaScript enabled to view it. .