12326BR

Title:

Sr. Specialist, Quality Records

Job Description:

Oversee the records management program to ensure quality, accuracy, and efficiency, while adhering to policies and compliance standards. This position encompasses records management, auditing, metrics and reporting, process improvement, discrepancy management, and data security. Job duties:

• Facilitate the records management program to ensure that the maintenance, retrieval, inventory, retention, and destruction of all records are in accordance with retention policy.

• Organize, assign, and process incoming records and requests promptly and accurately.

• Maintain an organized inventory, directory, or index of all records in the validated records management system.

• Partner with customers and team to ensure the correct and timely implementation of customer requests.

• Prepare metrics for records management, advise of changes, and recommend enhancements to existing processes.

• Verify other's work and perform audits to ensure accurate entry, filing, and maintenance of controlled documents and records.

• Provide instruction, training, or assistance to junior staff.

• Provide updates on current industry best practices and professional trends.

• Partner with stakeholders to digitize physical hardcopy records.

• Conduct research and retrieve information and documents as requested.

• Collaborate with stakeholders to determine and implement records management/ retention requirements specific to their functional area.

• Keep abreast of applicable regulations and emerging trends related to records management.

• Support set up and management of the secured archival room.

• Maintain knowledge of information governance, knowledge management, records management, and data security best practices.

• Responsible for the review of Quality Systems Records to ensure compliance and completeness to the records.

• Review batch records to ensure compliance with applicable GMPs, policies, procedures, and guidelines.

• Evaluate potential discrepancies detected in batch records and determine the need for a corrective action.

• Track/trend batch record discrepancies per procedural requirements and work with other departments to evaluate the discrepancies to establish necessary actions to reduce errors.

• Support Quality Systems training activities.

• Assist with Quality Training metrics management.

• Assist in preparation for audits and quality inspections.

• Provide full audit and inspection support.

• Trained in Doc Control process and provide back-up support as needed.

• Maintain high proficiency in departmental procedures.

• Assist in the development of departmental policies and procedures.

• Write and update departmental procedures to ensure efficiency, standardization, and accuracy.

• Provide input to Document Control Management on pending issues and proposed resolutions.

• Provide document and record assistance to internal customers.

• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.

• Perform additional duties as assigned.

Auto req ID:

12326BR

Location:

Aliso Viejo, California, USA

Department Name:

340-Document Control

Qualifications:

1. Bachelor’s degree or equivalent combination of education and experience.

2. Minimum five (5) years of Quality Systems experience in a medical device industry.

3. Knowledge of QSR, MDD, CMDR, EN ISO 13485, GCP, RDC ANVISA 16/2013, MHLW MO169, TG(MD)R Sch 3, TG(MD)R Statutory Rules No. 236, EN ISO 14971, and any applicable requirements of regulatory authorities participating in the MDSAP program.

4. Demonstrated strong knowledge of Records Management fundamentals, Quality Systems, and GMP requirements.

5. Experience with Records Management Systems.

6. Experience with internal and external audits.

7. Proficient with MS Office, including Word, Excel, Outlook, and Teams.

8. Strong attention to detail.

9. Strong written and verbal communication skills.

10. Good interpersonal skills.

11. Attentive to timely task completion.

Desired Qualifications

1. Document preparation and formatting experience/skills.

2. Audit support experience.

3. Training creation experience.

4. Knowledge of Quality System requirements.

5. Ability to handle multiple tasks at one time.

External-Facing Title:

Sr. Specialist, Quality Records

Posting Country:

US - United States

Salary Range:

$69,145 - $96,802 (Compensation could be higher based on education, experience and skill sets)

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.