Quality Assurance Specialist I - Irvine, CA

ISTA Pharmaceuticals is a publicly traded (NASDAQ: ISTA) specialty pharmaceutical company focused on the development and commercialization of unique and uniquely improved ophthalmic products for serious conditions of the eye. ISTA is currently promoting three FDA approved products; IstalolTM (for the treatment of glaucoma), Vitrase® (for use as a "spreading agent") and Xibrom (a topical ophthalmic NSAID for the treatment of post cataract surgery inflammation and pain. Recently ISTA filed it's fourth product, T-Pred, a combination steroid antibiotic with the FDA. We have other prescription products under development, including ecabet sodium, for the treatment of dry eye,  Caprogel® for the treatment of hyphema, Iganidipine and Latanaprost for the treatment of glaucoma, and Bepreve TM for the treatment of ocular allergies. In order to further build our pipeline as a specialty pharmaceutical company, we expect to acquire complementary products in ophthalmology, either already marketed or in late-stage development. Our management team has extensive experience in the development and commercialization of ophthalmic pharmaceuticals. Our Ophthalmology expertise can be found in the Marketing, Sales, Manufacturing, Clinical, Regulatory and General Management functions. For an exciting future with an exciting company, visit our website: www.istavision.com and click on "Careers". Quality Assurance Specialist I - Irvine, CA Overall Purpose: 

 

In a Pharmaceutical Quality Assurance department, perform data/document reviews, audit company systems, investigate/resolve non-conformances, and maintain change control systems.  Ensure company adherence to Good Manufacturing Practices (GMPs), Good Documentation Practices (GDPs), and internal procedures and protocols.

 

 Duties & Responsibilities:

 Primary Responsibilities  

• Review and approve Quality-related documents, including but not limited to: protocols; qualification, validation and stability reports; test results, including raw data; change control documentation; calibration certificates; and temperature charts

• Track and trend out-of-specification results, failure investigations, deviations, change controls (equipment and document), complaints, and recalls or field alerts

• Write and review procedures and other controlled documents

• Review executed manufacturing batch records for completeness and to ensure performance of operations according to batch records and applicable regulations and procedures; release acceptable batch records

• Periodic inspection of operations (including qualification and validation activities) to ensure compliance with written procedures, protocols, and regulatory requirements

• Create, issue, track, review, approve and/or control labeling materials

• Inspect and release clinical and manufacturing supplies, manufactured products, raw materials and/or chemicals

 

Other Responsibilities

 

• Provide QA guidance on validation activities

• Perform GMP, GLP, or GCP audits (internal and external)

• Provide training, as needed, and keep track of individual training needs, including follow-up with department supervisors

• Provide assistance to other personnel with regard to any Quality issues, including document retrieval and archival

• Maintain accountability for clinical supplies

• Play active role during regulatory inspections

Qualification Requirements:

 Education & Experience

 

Specialist I - B.A. or B.S. degree in a scientific field, e.g., chemistry, biology or pharmacology and 0-2 years related work experience.

Specialist II - B.A. or B.S. degree in a scientific field, e.g., chemistry, biology or pharmacology and 2-5 years related work experience.

 

 

 Knowledge, Skills & Abilities

 

Experience with validations / qualifications (equipment/instrumentation/methods/process) in a cGMP/cGLP/cGCP environment.  Thorough knowledge and understanding of the current Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and/or International Conference on Harmonization (ICH) guidelines.  Experience working in manufacturing and/or laboratory environment.  Have a good knowledge and understanding of practical quality assurance in the manufacturing environment, as well as laboratory controls and safety.  Ability to read, develop, and understand procedures and other controlled documents.  Good written and verbal communication skills, interpersonal skills, and technical writing skills.

 

Additional knowledge and skills preferred:

 

Knowledge and understanding of various software packages, specifically Microsoft Office, Software (Word, Access, Excel, Outlook, PowerPoint).  Should have the ability to work at a fast pace and handle multiple tasks, work with interruptions, prioritize workload, and deal effectively with confidential information, understand and implement written and verbal instructions.  Must have the ability to be flexible and proactive; able to practice good prioritization; maximize efficiency; and have good organizational skills.  Must be willing to work late or during weekends, if needed. 

 

Training Requirements:

 

Training to pertinent quality-related procedures, documents, and methodologies, safety, GMP/GLP/GCP/ICH requirements, and auditing.

 

 Physical Demands and Work Environment

 

The physical demand described here are representative of those that must be met by an employee to successfully perform the essential functions of this position.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

ISTA Pharmaceuticals offers a competitive total rewards package of cash compensation, benefits, stock options, and bonus programs. Employment is contingent on a successful background check and drug-screening result, and we maintain a smoke-free work environment. We are an equal opportunity employer committed to diversity in the workplace. EOE/M/F/V/D