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 innovative and customer oriented. Whether you are involved in manufacturing, testing, or compliance, your contribution will directly impact patients.
WHAT YOU WILL ACHIEVE
The Controlled Substance Site Operations Specialist, under the general supervision of the Manager, Site Controlled Substances, is a professional who is knowledgeable on all site matters in support of the controlled substance regulations as it pertains to pharmaceutical testing, manufacturing, and distribution of controlled substances. Through previous experiences and fundamental knowledge of controlled substances, the ideal candidate should be familiar with regulatory requirements impacting registration, procurement, and movement of material, production, shipment, and destruction.
This individual will use their operational knowledge to exercise judgment in decision-making to contribute to the completion of moderately complex, site-level continuous improvement projects. Uses experience and knowledge to ensure all records are complete and accurate to demonstrate inventory control and material accountability. Uses communication and analytical skills with limited oversight to identify, correct and resolve potential documentation inaccuracies. They will also assist with completing year-end inventories, inventory reconciliation and discrepancy investigations. Incumbents should have the fundamental skills and experience necessary to act and make moderately complex decisions in the Manager’s absence that are within company policy and regulatory requirements. This includes leading site regulatory inspections and interfacing with governmental agencies in the managers absence.
Continued compliance with DEA and state regulations is critical in ensuring Pfizer can consistently produce and distribute controlled substances and other prescription products. Failure to effectively support the manufacturing and commercial organizations could have significant implications to short term and long-term business strategies.
HOW YOU WILL ACHIEVE IT
Displays fundamental knowledge of controlled substance requirements, site operations and applies that knowledge and technical skills to lead reconciliation of site-controlled substance inventory by accurately reporting data on API, WIP, FG, Samples and Rejects in accountability tracking systems (Access database and Excel Spreadsheets).
Review ERP system transactions and hard copy batch records against accountability computational charts for accurate and up-to-date inventory tracking, taking appropriate remediation when necessary. Review and revise Controlled Substance related documents and SOPs for continuous improvement and enhancements within the facility.
Provide assistance to the Site and CS Manager for all CS waste shipments by ensuring waste is compliant with regulations for appropriate disposal via applicable DEA Forms and ensuring accurate inventories of the shipment by verifying quantities against primary source documents.
Responsible for the submission of all DEA and state required reporting by compiling and entering the applicable data- State reporting to responsible party on monthly basis, ARCOS monthly, YER and UN reporting on an annual basis.
Participate in Annual Controlled Inventory activities and compile Year-end Inventory data into reportable format.
Responsible for reviewing primary source documents for accuracy with required regulatory information, including but not limited to receiving paperwork, shipping paperwork, internal transfer records, batch records, Disposal reports, Inventory Cards, Sales reports, and Dispensing reports.
Support communication with local regulatory officials during inspections, inquiries and/or in the Manager's absence.
Act as point of contact between the site and regulatory agencies for the submission of controlled substance import and export requests via the online portal.
Create and maintain site import / export tracker to ensure compliance with the 30 days return document requirement.
Uses primary source documents to assist with the development, implementation, and instruction of training materials, including but not limited to: Diversion awareness, CDA training, Controlled Substance handling, Year-End Inventory, etc.
Incumbents will have the skills and experience necessary to act and make decisions in the Manager’s absence including leading regulatory inspections and interfacing with governmental agencies.
Participate in Audits/Inspections (DEA inspections)and act as a support host with the CS manager. Provide support to the site and CS manager to create an environment of inspection readiness for CS compliance by optimizing procedures, managing electronic documentation repository in support of readily retrievable documents, and providing up-to-date accountability for the site's applicable DEA registrations.
Provide guidance to other business units for Controlled Substance material transfers with external DEA registrants: including approving PO’s, initiating DEA 222’s, verifying Registrant status with DEA, overseeing tracking data.
Review and approve controlled substance purchases in the Ariba system.
Participate in or lead cross-functional teams with strategic site area owners, and other site CS Specialist to implement new controlled substance initiatives and standardize network processes related to Controlled Substances.
Assist with oversight and documentation of access to controlled substance areas.
Ability to read and interpret the CSCF "Controlled Substances Standard" document and apply the information to site level procedures or inquiries.
Maintain site quota tracking spreadsheet to ensure site does not exceed procurement above approved levels, when necessary.
Monitor CS inventory levels related to quota specific materials per regulations.
QUALIFICATIONS
Must-Have
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 work ethic, focused, able to prioritize workload with minimal supervision, detail-oriented, organization skills, able to multi‐task and follow‐up on open tasks; importantly, ability to execute on job functions in timely manner.
Proficient in the following software applications: MS Office (i.e., Access, Excel- tables, formulas, pivot tables, PowerPoint, Word, Outlook), Acrobat Professional.
Strong oral and written communication skills with ability to work with colleagues at multiple levels to determine the best path for successful completion of a task or project.
Must have experience with SAP- pulling reports, reviewing inventory/transactions.
Ability to review large quantities of documents for data and select key data points for tracking purposes.
Nice-to-Have
Experience in Controlled Substance Compliance.
Proficient in PDOCS system, primarily Author role with handling Impact Assessment, Training Risk Analysis, Knowledge Assessments, Forms (Smart and Fillable), SOPs.
Access to QTS/QMS as an Impact Assessor and Action Item owner.
Access to QTS/QMS as an approver.
Understanding of the flow of material through the facility
Previous experience operating under cGMP with a robust understanding of the principles and applications associated with manufacturing operations.
Previous experience working with auditors, inspectors, and regulatory agencies.
PHYSICAL/MENTAL REQUIREMENTS
Demonstrates skills to solve complex problems in a wide variety of high-pressure situations which require a high degree of ingenuity, creativity, and innovativeness. In situations where precedent may not exist, is able to independently exercise judgment, determine appropriate solution and act.
Strong work ethic, focused, able to prioritize workload with minimal supervision, detail-oriented, organization skills, able to multi‐task and follow‐up on open tasks; importantly, ability to execute on job functions in timely manner.
Professionalism - Approaches others in tactful manner; reacts well under pressure; treats others with respect and consideration regardless of status or position; accepts responsibility for own actions; follows through on commitments.
Quality - Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance; monitors own work to ensure quality.
Adaptability - Adapts to changes in work environment; manages competing demands; changes approach or method to best fit situation; able to deal with frequent change, delays, or unexpected events.
Initiative - Volunteers readily; Undertakes self-development activities; seeks increased responsibilities; takes independent actions and calculated risks; looks for and takes advantage of opportunities; asks for and offers help when needed.
Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; responds well to questions; demonstrates group presentation skills; participates in meetings.
Written Communication - Writes clearly and informatively; edits work for spelling and grammar; varies writing style to meet needs; presents numerical data effectively; able to read and interpret written information.
Sitting, standing, walking, ability to perform complex analyses and presenting to stakeholders.
Non-Standard Work Schedule, Travel, or Environment Requirements
This role is standard day Monday through Friday work shift; some off-shift support needed when issues arise.
OTHER JOB DETAILS
Last Date to Apply for Job: April 21, 2026
Additional Location Information: NA
Eligible for Relocation Package – NO
Secondment 8-10 months
If you are currently in a driving position with a fleet vehicle and this secondment does not require driving as an essential function of the position for 12 months or longer, you will be required to turn in your fleet vehicle for the duration of the non-driving secondment. Please refer to the Fleet Policy and Procedures document for more information.
There will be no change to your current work location.
Position is considered Flexible, and colleagues are expected to comply with Log In For Your Day (LIFYD) requirements at site location (e.g. about 2.5 days a week in office).
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
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 endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.