We currently have an open position for a Sr Quality Assurance Specialist reporting to our Quality Assurance department in the Irvine, location. 

RESPONSIBILITIES:

• Review all QC HPLC, GC, CE , AAS. TOC, UV, KF, FTIR and NIR assay and impurity results for Raw Materials, Finished Goods, Stability Products.
• Monitor all Controlled Products, Raw materials, Standards receiving, usage and inventory.
• Deacom Time editing for all QC analysts.
• Assisting Chemist whenever they have some questions on the procedures, analysis and tasks that they are assigned to.
• Train peers in reviewing all QC data results.
• Reviews all attachments corresponding to Raw Materials, Finished Goods, Stability Products.
• Facilitates the release of products by ensuring proper compliance of documentation in a cGMP and GDP environment.
• Ensures accuracy, integrity and completion of quality documentation and memos.
• Supports regulatory inspections, compliance audits and other quality functions.
• Assists with new product projects.
• Supplies documentation in a timely manner when requested.
• Assists the QA Manager in conducting Internal Quality Assurance audits.
• Performs other related duties as required.

QUALIFICATIONS:

• Bachelor’s degree in a scientific discipline.

• 6 years’ experience in a quality control or quality assurance function associated with a manufacturing operation; pharmaceutical experience preferred; or equivalent combination of education and experience.

• Strong organizational skills and attention to detail.
• Strong written, verbal and interpersonal communication skills and the ability to effectively interact cross functionally.
• Ability to handle multiple assignments and changing priorities.
• Ability to learn and utilize computerized systems for daily performance of tasks.
• Ability to prioritize, manage multiple tasks, and meet deadlines.
• Ability to understand, read, and write English.
• Ability to read and comprehend instructions, short correspondence, and memos, policy and procedures.
• Ability to effectively present information, answer questions, and professionally respond to any concerns in a one-on-one and small group situation.
• Ability to process, carry out and analyze vague, abstract verbal and written instructions.
• Proficient in Microsoft Word, Excel, Access, as well as other software packages.

Job Type: Experience 

Schedule: Full-Time 

At LGM Pharma, we always take pride in putting our people first. We are an equal opportunity employer.

All suitably qualified candidates will receive consideration for employment based on objective work-related criteria and without regard for the following: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws.