MQA Assistant

Location
92121, San Diego
Posted
Sep 04, 2018
Required Education
High School or equivalent
Position Type
Full time

Let’s Make Things Happen!

 

Ajinomoto Althea, Inc. is a fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies.

 

Althea is a leading expert in aseptic filling of drug product in vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation of recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services including: upstream and downstream process development, complex formulations, lyophilization cycle, analytical development, product release and ICH-compliant stability testing.

 

Now is an exciting time to join Althea. We have talented people working together to help our clients advance their innovative product pipelines. We believe that people are our greatest asset and we are committed to providing our employees with an environment that fosters personal and professional growth.

 

Our work atmosphere is fast paced, stimulating and customer focused. Employees take pride in knowing our efforts are helping countless patients for years to come.

 

Althea is currently seeking a Quality Assurance Assistant for our 2nd shift (3:00 – 11:30 pm). The QA Assistant is performing a wide variety of routine and semi-routine activities pertaining to assuring compliance with Quality Assurance (QA) requirements and applicable regulatory requirements, including assisting with audits and documentation review.

 

 

Responsibilities:

  • Performs logbook documentation audits for cGMP and GLP regulated logs. Performs Line Clearances for cGMP processes. Generates cGMP labels. 
  • Performs AQL inspection of final filled product. Responsible to review and reconcile cGMP label generation and packaging activities.
  • Reviews records and associated data in support of GMP operations activities.
  • Processes compliance documentation initiation, revisions, and deletions.
  • Assists in the distribution of compliance documents to all appropriate individuals and departments.
  • Ensures completeness and accuracy of information contained in all documents, document files, databases, and documentation systems.
  • Promotes GLP/cGMP environment and follows SOP’s.
  • Embodies Althea’s cultural values and aligns daily actions with department goals and company culture.          
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

Requirements:

  • High School Diploma or equivalent. Bachelor’s degree strongly preferred in a Life Sciences discipline or equivalent.
  • Zero to two (0-2) years of relevant experience in documentation, QA or equivalent.
  • Knowledge of cGMP regulations and good documentation practices preferred.
  • Ability to distinguish one or several chromatic colors, independent of the capacity for distinguishing light and shade.
  • Detail oriented and strong written and verbal communication skills.
  • Ability to work independently, within prescribed guidelines, or as a team member.
  • Demonstrated ability to follow detailed directions in a laboratory environment.
  • Must be familiar with Microsoft Office applications.

If you meet the requirements above, and would like to apply for this position, please visit our website at www.altheacmo.com and click on the "Careers" section.  Please be sure to note where you saw our ad posting.

 

Successful Candidate must pass a background check and drug screen as a condition of employment.

 

We are an EOE dedicated to a diverse work force and Drug Free work environment.

 

Qualified M/F/D/V candidates are encouraged to apply.