Use Your Power for Purpose At Pfizer, the impact you will have on improving patients' lives is profound. You will play a crucial role in navigating and interpreting the growing regulatory demands to ensure optimal patient care. Your expertise and commitment are crucial in adapting to these changes and maintaining the highest standards of patient care. Join us in our mission to make a global impact on patient care.
What You Will Achieve In this role, you will:
- Lead the creation, review, and revision of documents (SOPs, forms, jobs aids, training material, batch records, etc.) and other manufacturing department documents.
- Work with production operations technicians and supervisors to understand the objective of each document to ensure that all documents contain the required content.
- Interpret information and organize it properly for accuracy, readability, and formatting, while ensuring the proper grammar and spelling is used in all documents.
- Perform all duties in a manner consistent with site and corporate cGMP, safety, environmental and human resources policies and procedures.
- Edit and format incoming requests for new or revised manufacturing documents and assist in tracking each revision through the approval process.
- Collects and analyzes the information necessary to complete the creation and revision of forms, compound records, and batch records.
- Reviews the impact of the proposed changes with regards to other support documents.
- Support the development of new and revised documents, including suggestions for suitable terminology, content, and format while ensuring that site policies comply with corporate guidelines.
- Participate in the review of Standard Operating Procedures, batch records, compound records, forms and other related GMP documents.
- Assist in maintaining control of documentation to include accurate document history and change revision documentation.
- Coordinate the issuance, tracking, and review of batch records and other controlled documents to ensure target product-based cycle times are met.
- Support the reconciliation and changeover of controlled prints.
Here Is What You Need (Minimum Requirements):
- Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience
- Strong interpersonal communication and problem-solving skills.
- Ability to learn and navigate document control and e-systems to facilitate document routing and approval.
- Ability to effectively proofread documents prepared by self and others to ensure content and formatting accuracy.
- Ability to write clearly and concisely with strong English background with excellent grammar, good writing skills, and knowledge of sentence structure.
- Ability to translate verbal guidance into precise operating instructions.
- Ability to learn and understand pharmaceutical processes to design related SOPs.
- Proficiency in Microsoft Office Suite, Adobe Acrobat, and other computer skills.
Bonus Points If You Have (Preferred Requirements):
- Prior experience with electronic quality systems (ie. PDOCs, QTS, eQMS, EAMs, etc.)
- Demonstrated experience in the pharmaceutical industry
- Robust knowledge of local manufacturing processes and procedures
PHYSICAL/MENTAL REQUIREMENTS - Role requires ability to gown into manufacturing areas, potentially standing for several hours continuously.
- Extended time looking at computer monitors.
- Sitting for extended periods.
Work Location Assignment: On Premise
The annual base salary for this position ranges from $66,500.00 to $110,900.00. 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
