Quality Assurance Analyst II - (US-CA-Irvine - 92710)

Minimum Education: Bachelors
Job Type: Full Time
Jobcode: 3165
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Our client is a leading producer of therapeutic peptides for pharmaceutical and biotech companies. They operate from two locations – in Brussels, Belgium and in Torrance, California. They are committed to serving the pharmaceutical and biotech industries with the production of cost-effective and high-quality bulk peptide APIs based on close and long-term relationships with customers. The company has an experienced management team, a varied selection of interesting protocols and an empowering corporate culture that is focused on the long-term professional development of it's employees.

Job Responsibilities:
1) Execute the non-GMP storage and electronic database for custom peptides and update customer files
2) Ensure the weighing and dispensing of GMP and non-GMP key raw materials to production
3) Ascertain the shipping of both GMP and non-GMP products to customers
4) Ensure distribution of documents
5) Make new/revised Standard Operating Procedures (SOPs) master batch records, change control system, specification and test method manuals
6) Review and approve raw materials releases done by QC unit
7) Operate general analytical instruments during testing (i.e., HPLC, GC, UV, TOC, FTIR, moisture apparatus, balances, etc.)
8) Maintain BSE/TSE files
9) Participate in internal audits
10) Provide backup support for the QA Manager
11) Perform environmental monitoring trending and water system data trending
12) Write and review SOPs
13) Perform related duties as assigned

Job Requirements:
1) BA in Science
2) 2 – 3 years of experience in an FDA-regulated environment
3) Good analytical techniques to perform tests
4) Excellent communication skills (oral and written)
5) Superb computer skills including Microsoft Windows
6) Team-oriented
7) Ability to perform duties with minimal supervision
8) Ability to work in fast-paced environment (at times under pressure and with tight deadlines)
9) Detail-oriented with ability to multitask

Applicants are encouraged to apply directly by going to: http://www.sterlinglifesciences.com/jobs/lifesciences-jobs-03165.html