What are the responsibilities and job description for the SOP Specialist position at Pfizer?
ROLE SUMMARY
The Documentation SOP Specialist manages the electronic check-in/check-out, processing, distribution and upload of site documents for the Rocky Mount site utilizing PDOCS, the Rocky Mount document management system. The SOP Specialist manages updates, changes, and deletions of site controlled documents utilized in the production environment; including but not limited to standard operating procedures, templates, work instructions, and placards. The documentation specialist is responsible for tracking each update through the approval and implementation of each document to meet its timeline utilizing a spreadsheet. The Documentation SOP Specialist provides support to site SMEs/document owners on the change order process. Demonstrates problem-solving techniques, cross-training and trainer for new employees.
ROLE RESPONSIBILITIES
- Process site documents through lifecycle functions in PDOCs, including but not limited to, creation, updates, changes, deletions and obsoleting of documents.
- Manage the Periodic Review Process for all site SOPs.
- Manage the Placard process for the site
- Audit and review all formatting to SOPs, Job Aids and Form templates to maintain the integrity of the templates issued.
- Provide support for all site projects
- Maintenance and organization of the Check in/Check out process for SOPs, Job Aids and forms in the PDOCS system and issuance of documents to SME/document owner for editing within the timeframe provided.
- Audit of Change Requests, SOPs, Job Aids, Forms and supporting documentation in the change process to comply with GXPs and works extensively with SME/document owners on requirements for supporting documents
- Provides department metrics for area and manages projects that involve SOPs and Forms
- Manage the matrices that include SOP owners, QA Approval and Form excel spreadsheets
- Provides support to SME/document owner
- Manage filing of all Documents in the Gamma Facility
- Performs problem-solving techniques
- Cross-trains within department for continued growth
- Maintenance of printers, notifying BT when issues occur; and provide inventory of paper and form stock to meet department needs.
- Perform other related duties as assigned or required
Basic Qualifications
- Associates degree, an additional 1 year experience in controlled document management/records management position required or High School Diploma and 3 years’ experience in controlled document management/records management position required.
- Strong attention to detail and excellent written and verbal communication skills.
- Strong reading comprehension and proof reading skills, strong organizational skills.
- Thorough knowledge of cGXP.
- Proficient in Microsoft Office (Word, Excel)
- Ability to work independently and multi-task in a fast, priority –switching environment.
- Demonstrated ability to work/contribute in a team-based environment.
- Team and customer oriented.
- Ability to facilitate process improvements.
- Ability to load printers, lift paper stock and limited ability to troubleshoot printer.
PREFERRED QUALIFICATIONS
- Ability to write procedures and update area SOPs, Job Aids and forms as needed.
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
Nice-to-Have
Strong reading comprehension and proofreading skills .
Strong organizational skills .
PHYSICAL/MENTAL REQUIREMENTS
- Must be able to lift 30 lbs
- Ability to bend, twist and use fine motor skills
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Must be willing to work overtime to meet site needs including weekends and off-shift hours, as needed
Other Job Details:
- Last Date to Apply for Job: March 23, 2022.
- Eligible for Relocation Package: No
- Eligible for Employee Referral Bonus: Yes.
#LI-PFE
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
