BRQ Documentation Specialist

Company: myGwork
Location: Rocky Mount
Posted on: January 27, 2023

Job Description:

Why Patients Need You A career with us is about discovering breakthroughs that change patients' lives. A high performing administrative team is essential to bringing those therapies to people all over the world and making a positive difference. We need dedicated colleagues like you who are efficient, find solutions and collaborate with others to achieve our purpose. What You Will Achieve Your strong communication and collaboration skills will help the team to run its operations efficiently. You will focus primarily on administrative coordination to functional areas. You will also be responsible for managing records and files, verifying data, responding to mails and scheduling meetings, amongst other things. As part of the administrative support team, you will participate in process improvement and collaborating with others by sharing experiences. Your skill and knowledge will help in making decisions that require choosing among limited options. You will be proactive in leveraging your team' knowledge to learn and develop your own work products. Your systematic approach and organizational abilities will ensure that communication between departments and teams is seamless. It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe. How You Will Achieve It The Batch Record Quality Documentation Specialist: Supports batch record storage in alignment with the document retention policy including off-site storage. A ssists in the batch record archival process at the Rocky Mount site for commercially distributed products (domestic and international). Ensures that each batch record has been cataloged, barcoded and archived appropriately. Supports the collection of defect data from the 100% visual inspection process of commercial products manufactured at the Pfizer, Rocky Mount site. A ssists in the timely retrieval of requested records in support of investigations, inspections, PC1, BR corrections, and external requests. Ensures proper and timely return and storage of all retrieved records. Qualifications Must-Have Organizational skills and attention to detail. Excellent interpersonal and communication skills (oral and written). Familiarity with batch records and other GMP documentation. Proven ability to work with minimum supervision. Nice-to-Have Associate's degree or a minimum of 4 years of experience working in a regulated industry. Basic knowledge of cGMPs and FDA requirements. Demonstrated proficiency in computerized systems. PHYSICAL/MENTAL REQUIREMENTS P osition will require lifting, sitting, standing, and walking. A bility to perform mathematical calculations and complex data analysis. May be required stand up for periods of up to four (4) hours. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS May require some overtime or weekend work to meet the department requirements as needed. R equired to adhere to all safety policies and procedures along with cGMP, regulatory requirements, internal Standards. Travel for this position is minimal to none. Last Date to Apply for Job: August 19th, 2022 Eligible for Relocation Package: NO Eligible for Employee Referral Bonus: YES LI-PFE21 Relocation assistance may be available based on business needs and/or eligibility. 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. AdministrativeLI-PFE This employer is a corporate member of myGwork - LGBTQ professionals, the business community for LGBTQ professionals, students, inclusive employers & anyone who believes in workplace equality.

Keywords: myGwork, Rocky Mount , BRQ Documentation Specialist, Other , Rocky Mount, North Carolina