QA Specialist - II

Unicon Pharma Inc; El Segundo (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Unicon Pharma Inc. seeks a QA professional to oversee Deviations, OOS, CAPA, and change controls in a biologics manufacturing setting. The role ensures investigations follow GMP timelines and collaborates with cross-functional teams to resolve manufacturing and environmental issues.

Qualifications include a Bachelor’s in biological sciences with 2+ years of relevant experience, GMP knowledge, and proficiency with MS Word, Excel, and PowerPoint. Occasional night/weekend support may be required.

Qualifications

• Bachelor’s degree in biological sciences or equivalent with 2+ years experience.
• GMP knowledge and familiarity with US/EU standards is preferred.
• Experience QA/QC in a biologics/manufacturing environment is highly valuable.

Responsibilities

• QA oversight and approval of Deviations, OOS, Change Controls, CAPA, and EV records.
• Ensure investigations, escalations, and resolutions meet GMP procedures and timelines.
• Support resolution of manufacturing, product, environmental, facility, equipment, and material issues.

Skills

GMP knowledge

QA/QC in biologics/manufacturing

Deviations, OOS, CAPA, Change Controls

Communication & collaboration

Night/weekend manufacturing support

MS Word

MS Excel

MS PowerPoint

Education

Bachelor’s + 2+ years relevant biological sciences or equivalent

Tools

MS Word

Excel

PowerPoint

Job description

Schedule: Monday-Friday; occasional nights/weekends during manufacturing campaigns.

Core Responsibilities:

• QA oversight and approval of Deviations, OOS, Change Controls, CAPA, and EV records.
• Ensure investigations, escalations, and resolutions meet GMP procedures and timelines.
• Support resolution of manufacturing, product, environmental, facility, equipment, and material issues.
• Identify process efficiencies while maintaining compliance.
• Work collaboratively in a fast-paced manufacturing environment.

Must-Haves:

• Bachelor’s + 2+ years relevant biological sciences experience, or equivalent education/experience.
• GMP knowledge, preferably U.S. and EU standards.
• Experience with QA/QC in a biologics/manufacturing environment is highly valuable.
• Strong experience with Deviations, OOS, CAPA, and Change Controls.
• Strong communication, collaboration, and problem-solving skills.
• Proficiency with MS Word, Excel, PowerPoint.
• Flexibility for occasional night/weekend manufacturing support.