QA Document Control in Livermore, CA at Apex Life Sciences

Date Posted: 8/8/2018

Job Snapshot

Job Description


 The following is a list of essential duties and responsibilities for this position along with certain supportive duties. This list is not all-inclusive. This position requires attention to detail, strong problem identification/analysis skills and ability to interaction with all departments internally.

Job Responsibilities:

? Review the batch records and release of finished products.

? Assist with development and implementation of departmental procedures and best practices

? Administration and management of GMP documents including Policies and Corporate SOPs

? Maintain accurate and current Quality records.

? Performs QA document control functions, including document login, processing, verifying, distributing, filing, and archiving

? Prepare applicable documents for submission to customer

? Communicate with other departments applicable quality or document requirements

? Communicate with customer applicable production and quality documents

? Assist Quality Management with FDA and other regulatory agency activities including inquiries, notifications, and document submissions

? Perform other duties as assigned, or as business needs require

? Save records in Master control.

Qualifications:

? Bachelor’s Degree in Science.

? Experience in the QMS Master Control is preferred.

? Preferable to have 1-2 years’ experience in FDA regulated industry Quality environment supporting US FDA products.

Skills:

? Preferable to have some experience in pharmaceutical industry Quality Assurance environment supporting US FDA pharmaceutical products

? Possess an understanding of cGMP/compliance requirements for cosmetic and pharmaceutical products

? Attention to details

? Ability to manage timelines and priorities

? Ability to work independently with minimum guidance

? Ability to multi-task

? Excellent verbal and written communication skills

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.