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Senior Policy and Documentation Specialist

San Diego Blood Bank

San Diego, CA | Full Time

$86k-108k (estimate)

4 Days Ago

Senior Policy and Documentation Specialist

San Diego Blood Bank San Diego, CA

$86k-108k (estimate)

Full Time | Ancillary Healthcare 4 Days Ago

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San Diego Blood Bank is Hiring a Senior Policy and Documentation Specialist Near San Diego, CA

Job Summary

The Senior Policy and Documentation Specialist proactivity guides and oversees policy management and technical documentation needs of San Diego Blood Bank.

Responsibilities

Create, implement, and maintain a document management system that manages internal and external controlled documents.
Provide relevant training on document control procedures and good documentation practices.
Assist the Quality Assurance and Compliance Department in creating quality plans and procedures.
Assist in initiating, investigating, and closing product and process deviations/non-conformances.
Recommend corrective action for quality issues.
Assist in preparation for customer audits and regulatory and accreditation inspections.
Review documentation to assure accuracy and completeness.
Author and revise policies, procedures, and other related quality documents.
Manage document processes and systems to ensure control and availability of documentation to personnel.
Assign a control number to document change requests.
Assist in data mining and trending of quality issues.
Support all activities related to document control in GMP manufacturing.
Review documentation procedures and other documents to ensure compliance with relevant good manufacturing and good laboratory practice requirements.
Coordinate the approval process, including facilitating and executing documentation through the document change control process.
Monitor the periodic review process for documents.
Distribute official documents to internal and external customers as needed.
Ensure that documentation complies with established document management system standards/requirements.
Assist in identifying when new policies are needed based on research, national standards, and industry best practices.
Research and analyze policy and procedure effectiveness, formulate recommendations as appropriate and maintain documentation of changes.
Ensure that policies, procedures, and other supporting documentation is current, accurate, and written in formats consistent with policy formatting, tone, and language best practices.
Attend document management meetings, record proceedings, and ensure established deadlines complete follow-up activities.
Perform tasks to assist the Quality and Compliance Committee with requested deliverables and projects.
May lead or participate in special projects directed to the continual improvement of the department or other cross-functional projects.
Ensure compliance with all applicable state and federal laws and regulations and with the standards of accrediting/certifying agencies.
Understand and adhere to the policies, procedures, and standards as developed as part of the San Diego Blood Bank Compliance Program.
Perform other related duties as assigned or requested.

Working Environment

Normal office environment

Physical Requirements

May be subject to prolonged sitting, reaching horizontally.
Must be able to work 4 - 8 hours a day on a computer.
Must be able to move around the office and stand for prolonged periods.
Must have the ability to travel to mobile or fixed collection sites and off-site meetings.

Equipment Used

Standard office equipment includes computers, telephones, copy machines, fax machines, and scanners.

Qualifications

Education:

Bachelor’s degree in a work-related field/discipline from an accredited college or university or equivalent combination of education, training, and experience.
Advanced degree preferred.
N/A

Experience:

Quality professional with at least four (4) years of hands-on experience with document control and change management in a regulated industry.
Experience with writing policies, procedures, validations, process workflows, and/or handbooks is required.
An expert understanding of grammar, sentence structure, and intended audiences is required when drafting, reviewing, and editing documents or messages.
Experience in the Quality Management System areas, including exception management, change control, and document control.
Experience with Quality Management System software. Experience with MasterControl preferred.
Audit or inspection experience is required.

Knowledge, Skills, Abilities:

Working knowledge of quality systems and GMP-related requirements.
Knowledge of electronic documentation systems.
Must demonstrate leadership skills through example.
Ability to effectively manage multiple priority projects and adhere to tight deadlines.
Must be able to work effectively and efficiently in a team environment.
Ability to approach challenges with confidence.
Proficient in Microsoft Suite applications (Excel, Word, PowerPoint).
Strong technical writing and editing skills.
Superior attention to detail.
Ability to communicate effectively, verbally and in writing, and demonstrate good interpersonal skills interdepartmentally and with external vendors and contractors.
Ability to recommend solutions backed by strong analytical and critical thinking skills.
Demonstrated ability to communicate complex concepts that non-subject matter expert end-users can easily understand.
Ability to use effective problem-solving techniques and make sound decisions.

The above statements describe the general nature and level of work being performed. This job description is not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Ancillary Healthcare

SALARY

$86k-108k (estimate)

POST DATE

05/09/2024

EXPIRATION DATE

07/08/2024

WEBSITE

sandiegobloodbank.org

HEADQUARTERS

SAN DIEGO, CA

SIZE

200 - 500

FOUNDED

1950

CEO

RAMONA WALKER

REVENUE

$50M - $200M

INDUSTRY

Ancillary Healthcare

Related Companies

About San Diego Blood Bank

The San Diego Blood Bank is a non-profit 501 (c) (3) organization that is the primary blood provider to the majority of hospitals in San Diego County. It has also launched a Cell Therapy Center & collects cord blood units at Scripps Mercy Hospital. It operates 24-hours-a-day, seven-days-a-week, 365 days a year.