QA Specialist - Document Control
Job Description
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.
What You Will Achieve
You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer’s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
The QA Specialist, Document Control is responsible for document management system use and end user support at the Sanford North NC site. The role manages document workflows within the Pfizer global electronic document management system, provides administrative approval for document promotion workflows, and provides inputs to document standards including formatting requirements. This position also aids with controlled document issuance, reconciliation and executed document archival.
This role is responsible for logbook issuance, executed batch record issuance, and coordinating client/ third-party approval for master and executed batch records.
This role is responsible for managing local document library, archiving records in accordance with Pfizer Controlled Index of Company Records (CICR) standards, and recall for executed records to support internal, corporate, third-party, and regulatory audits.
Role Responsibilities
Issue and Manage documents through various workflows in the electronic document management system
Ensure documents meet procedural requirements for formatting, training assignments, properties, and related meta-data
Issue/ recall official document prints including business continuity folders for the site
Manage physical document library, prepare records for archive per CICR requirements, and retrieve records as required
Deliver site-level end user support and training for the Pfizer global electronic document management system
Serve as document author and SME for document management processes
Ensure Master Batch Records, Specifications, Laboratory Methods, Protocols, and similar cGMP documentation receive client/ third-party approval prior to implementation.
Complete logbook and executed batch record issuance activities.
Interface with cross-functional teams such as Operations, Training, Quality Management, Engineering, Maintenance, Supply Chain, etc. for Document Control functions supporting the site.
Qualifications
Must-Have
Applicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience OR an Associate's degree with 4 years of experience OR a Bachelor's degree with 0+ years of experience.
Experience with proofreading/ formatting documents
Experience in GMP enviroment
Proficient with word, excel, etc. Skilled at reviewing and editing own/other’s work.
Skilled with computer work and programs.
Organizational and filing skills.
Skills with customer service/interaction with others.
Ability to work in a team environment within own team and interdepartmental teams
Effective written and oral communication skills
Nice-to-Have
Experience executing transactions in a Document Management System
Experience conducting classroom and on-the-job training sessions
Physical / Mental requirements
Long periods of sitting when performing transaction in Document Management System or CICR·
Must maintain attention to detail when processing large quantities of documents on a routine basis
Ability to lift up to 20 pounds 2-3 times per day
Non-Standard work schedule, travel or environment requirements
Occasional late night or weekend work may be required depending on business need.
Other job details
Last day to apply; March 15th, 2024
Employee Referral Bonus eligible
Work Location Assignment:Flexible
The annual base salary for this position ranges from $64,600.00 to $107,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.
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. This position requires permanent work authorization in the United States.
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.
