Job Description

ROLE SUMMARY

The QC Documentation Coordinator is a member of QC capable of performing accurate data gathering, tabulation and/or summaries, verification and advanced word processing. Data gathering will be required from laboratory instrument software and other electronic systems such as Empower and LW LIMS. The Documentation Coordinator will also coordinate activities involving documentation needed for CMC submission, Annual Reports, APQRs and query responses as well as routine laboratory and stability reporting. The person will also support creation and revisions of QC documentation such as SOPs, protocols and reports for QCA and QC Stability. Prepares and reviews required documentation following good manufacturing practices (GMP). Utilizes related documentation systems. Coordinates the review and revision of procedures, specifications, and forms. Provides input on quality control procedures and documentation.

Position exists to facilitate data gathering, data verification and the review cycles to ensure consistency and completeness in the final document. A person in this position uses her knowledge of documentation systems to support efforts to identified issues needing attention, and to problem-solve.

ROLE RESPONSIBILITIES

* Data gathering and/or verification for a variety of analytical and stability documentation.
* Formatting CMC submissions, Annual reports, APQRs and query responses in preparation for review cycles.
* Formats documents using advanced word-processing skills. Skillfully handles formatting of complex tables and graphics. Ensures that documents meet CTD requirements.
* Ensures submission sections and other documentation are complete, in order, paginated, and ready for review.
* Generates review copies and distributes to reviewers.
* Follows up with authors and reviewers to resolve issues.
* Finalizes documents and delivers to Regulatory Affairs Documentation (RAD) for submission to regulatory agencies.
* Support creation and revisions of QC documentation such as SOPs, protocols and reports for QCA and QC Stability.
* Collaborates with other function areas to resolve issues related to data content and formatting documents.

BASIC QUALIFICATIONS

* Bachelor's Degree with 2+ years of relevant work experience OR Master's Degree with 0-3 years of relevant work experience required.
* Relevant Quality experience, preferably in the bio/pharmaceutical industry.
* General knowledge of cGMPs.
* Strong technical writing skills.
* Proficiency with computer systems Microsoft Office applications, MS Word, EXCEL, Access, data analysis software.
* Strong interpersonal and communication (written and oral) skills and the ability to work well in a team environment are essential).

PREFERRED QUALIFICATIONS

* Experience with LabWare LIMS, QTS Trackwise, PDOCS or similar document management systems.

PHYSICAL/MENTAL REQUIREMENTS

* Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (Laboratory).
* Ability to perform mathematical calculations and to perform complex data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

* Position is first shift Monday through Friday. Some off hour support may be required to support priorities.

Additional Job Details:

* Last Date to Apply for Job: 05 JANUARY 2020

* Referral Bonus Eligible

* LI-PFE

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 providers 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.

Quality Assurance and Control

LI-PFE