Quality Assurance Manager
Norac Pharma is recruiting for qualified Quality Assurance Manager Candidates for our Quality Assurance Department.
Norac Pharma is a premier Contract Manufacturing Organization for Active Pharmaceutical Ingredients. We are located in Azusa CA, approximately 12 miles east of Pasadena near the 210 and 605 freeway junction. We are a privately held corporation and have been in business since 1957.
For more information, please visit our website: http://www.noracpharma.com/
JOB TITLE: Quality Assurance Manager
DEPARTMENT: Quality Assurance
- The Quality Assurance Manager will oversee and manage the operations and systems of the Quality Assurance Department in support of the manufacture, testing and release of finished Active Pharmaceutical Ingredients.
- To ensure that all cGMP requirements are being met by all departments engaged in the development, manufacture, processing, packing, analysis, holding, or distribution of product.
- Provide continuous and proactive QA oversight.
- Develop any needed procedures for the Quality Assurance function.
- Manage the Norac Pharma Document Control and Quality Systems function.
- Administer the quality systems (e.g., change control, deviation system, internal audit program, supplier qualification program, training program, customer complaint program, etc.).
- Ensuring that the employees within their respective section(s) have the education, training, and experience, or any combination thereof, to perform assigned functions.
- Ensuring that the employees within their respective section(s) comply with the current Good Manufacturing Practices.
- Host external audits by clients and regulatory agencies.
- Audit and review of raw materials, intermediates, final product analytical reports, and batch records.
- Approval/rejection of labels, intermediates and finished product.
- Review and approve any training curricula.
- Inspection, verification and approval of all labeling and artwork.
- Evaluate and approve investigations, and perform QA Assessments for quality systems (e.g., deviation system, OOS system, customer complaints, etc.).
- The hiring and training of the Quality Assurance personnel.
- Develop and provide GMP and Quality Systems training.
- Interact with all Regulatory Agencies during the course of audits and/or other relevant interactions.
- Schedule external client audits and coordinate internal resources necessary for the audit.
- Perform Annual Product Reviews.
- Perform internal and external audits as required.
- Review and approval of documents such as SOPs, analytical methods, master batch records, specifications, and validation documentation.
- Write and revise documentation, when appropriate.
- Perform trending of product data and quality systems.
- Supervise assigned Quality Assurance personnel.
Education / Experience / Personal Requirements:
- Degree in Science, preferably in Chemistry or related field.
- Minimum five years experience in a Quality Assurance position.
- Good interpersonal and leadership skills.
- Detail oriented with critical thinking skills.
- Ability to operate in a decentralized environment.
- Ability to manage multiple tasks and prioritize work.
- Self-motivated with strong organizational and time management skills.
- Proficient in Microsoft Office applications (advanced knowledge of MS Word and Excel is preferred).
- Prior experience in MasterControl or electronic document management system a plus.