Senior QA Associate - Chandler, AZ | Biospace
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Senior QA Associate

Insys Therapeutics

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Location:
Chandler, AZ
Posted Date:
8/1/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Associate, QA, Quality Assurance,

Job Description


PURPOSE:

The Senior Quality Assurance Associate is responsible for working in the Quality Assurance department and assisting with maintaining compliance to the overall Corporate Pharmaceutical Quality Systems.  Specific job duties will include managing pharmaceutical Quality Assurance processes including vendor qualification (evaluating and auditing vendors for compliance), intake and processing of customer product complaints, review and approval of production documents (deviations, batch records, etc.), internal audits, record retention, change control, specifications, and document distribution.  Assistance in the management of the corporate Quality Management Software (QMS) is also required.  Applicant must have hands-on pharmaceutical QA experience.

RELATIONSHIPS:

The position Reports to the Supervisor of Quality Assurance and will have interactions with member of other departments including Quality Control, Analytical/Stability, Manufacturing Quality Assurance, R&D, and outside customers.

DUTIES AND RESPONSIBILITIES:

•   Manage Vendor Qualification System, including interactions with vendors to facilitate the completion of vendor surveys, perform risk analysis, audit, and write audit reports.
•   Audit vendors as required by internal procedures, includes coordination of travel, audit, and providing audit reports to the vendor.
•   Manages the controlled substance activities which include: ordering and completing DEA 222 forms; receiving, logging, and issuing controlled substances for laboratory testing; maintaining, auditing and reviewing logbooks; other activities as directed.
•   Manage the Product Complaint process including the intake, processing, investigating, and trending of complaints.  This includes speaking with patients and timely follow-up with vendors, physicians, pharmacists, and other applicable stakeholders as needed.
•   Maintain the Product Complaint database including trending of all complaints and ensuring appropriate information is provided to senior management.
•   Route manufacturing and quality documentation to vendors and Insys management for consensus and approval.
•   Initiate, review and route deviations and non-conformance documents.
•   Issue, review, and approval Change Controls (CCs) related to all controlled documents.
•   Manage physical inventory of documents control including documentation in the file room and electronic database of documentation
•   File and maintain records in accordance with established policies, procedures and regulatory requirements, Including Change Control and QA  
•   Perform QA document review on Manufacturing and Quality documents.
•   Maintain master, obsolete and archive files (electronic and paper)
•   File and maintain records in accordance with established policies, procedures and regulatory requirements
•   Establishes training for other departments, works independently to contact and train employees in other departments.
•   Writes, reviews, and revises SOPs, Protocols, and other company documents as required from supervisor.

Requirements


QUALIFICATIONS (Education, Experience, Knowledge, and Skills):

•   Bachelor of Science in Chemistry or related field; Life Science degree preferred
•   CQA or other quality auditing certification highly desired
•   At least 5 years of related experience in the pharmaceutical industry (commercial environment)
•   At least 2 years of pharmaceutical/device auditing experience required (internal and external auditing)
•   Extensive GMP knowledge; Familiarity with GCP regulations; Knowledge and experience of the current requirements of FDA and ICH Guidelines along with hand-on experience managing regulatory inspections
•   Must have thorough understanding of applicable regulations/guidelines to facilitate the interpretation and impact of Quality related issues
•   Ability to utilize resources for GMP related activities (manufacturing, complaints, AE’s)
•   Must be willing to travel, approximately 30-50%
•   Strong English written and verbal communication skills are required
•   Ability to interact effectively in a team based environment
•   Ability to work independently and work with limited direction
•   Experience with electronic QMS systems preferred

WORKING CONDITIONS / PHYSICAL REQUIREMENTS:

Standard office environment.  Should to be able to lift objects up to 25 pounds.

Overnight travel required. 30-50%.

DIRECT REPORTS:

No direct reports.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Additionally, this job description reflects management’s assignment of essential functions.  It does not prescribe or restrict the tasks that may be assigned.