Controlled Substance Site Operations Specialist

WHY PATIENTS NEED YOU

Everything we do, every day, reflects an unwavering commitment to the quality and delivery of safe and effective products to patients. A strong, compliant, and collaborative organization is essential to ensuring those products reach patients around the world.  

WHAT YOU WILL ACHIEVE

The Controlled Substance Site Operations Specialist, under the general supervision of the Manager, Site Controlled Substances, provides operational support for site activities related to controlled substance regulatory compliance. You will collaborate across functional areas to support site operations and represent Controlled Substance Operations on cross-functional activities, as needed. 

Using controlled substance knowledge and operational experience, you will ensure controlled substance records are complete and accurate to demonstrate inventory control and material accountability. You will use organizational and communication skills to identify and resolve documentation inaccuracies. You will also support year-end inventories, reconciliation, and discrepancy investigations. 

In the Manager’s absence, you may need to make operational decisions that include communicating with site leadership for controlled substance matters, supporting regulatory inspections, and approving critical documentation.  

Continued compliance with DEA and applicable state controlled substance requirements is critical to Pfizer's ability to manufacture and distribute controlled substances and other prescription products. Your work will help maintain regulatory compliance and reliable product supply in support of patients. 

HOW YOU WILL ACHIEVE IT

• Apply knowledge of controlled substance requirements and site operations to support site compliance of manufacturing, testing, storage, movement, and distribution of controlled substances. 

• Review SAP transactions, batch records, computational charts, inventory records, and other primary source records to verify completeness and accuracy of accountability data for all controlled substance materials at the site. 

• Identify documentation and accountability discrepancies, communicate issues to appropriate management, and support investigation. 

• Support annual controlled substance physical inventory activities and compile Year-End Inventory data into the required reporting format. 

• Compile and support submission of required DEA reporting: monthly and yearly ARCOS reporting, Year-End Reporting, and UN reporting. 

• Support controlled substance receipt and shipment activities for testing and the stability program, including reviewing receipt and shipment records, documents, and spreadsheet. 

• Support controlled substance waste and destruction activities, including reviewing shipment inventory spreadsheets and completed DEA Form 41 after disposal. 

• Support controlled substance procurement and transfers, including purchase order review, verification of DEA registrant status, and approval of purchases in Ariba. 

• Participate in cross-functional activities with site area stakeholders to implement controlled substance initiatives and support standardization of network processes. 

• Review and revise controlled substance procedures and supporting documentation. 

• Participate in audits and regulatory inspections, as needed. 

• Assist with oversight and documentation of access to controlled substance areas. 

• Provide coverage for the Site Controlled Substances Manager as needed, exercising judgment within established company procedures and regulatory requirements. 

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 organizational, time-management, and prioritization skills, with the ability to manage multiple activities and complete work accurately and on time. 

• Strong attention to detail and demonstrated ability to review large quantities of documentation, identify key information, and accurately maintain data and records. 

• Proficiency with Microsoft Office applications, particularly Excel and Word. 

• Strong written and verbal communication skills, with the ability to collaborate effectively across multiple functional areas and organizational levels. 

• Ability to take direction, work with limited supervision, exercise sound judgment, and escalate issues appropriately. 

• Experience working in a regulated or manufacturing environment with an understanding of the importance of accurate documentation and data integrity. 

Nice-to-Have

• Experience working in a cGMP pharmaceutical manufacturing environment and an understanding of manufacturing operations and material flow through the facility. 

• Experience with SAP, including reviewing transactions and generating reports. 

• Advanced Microsoft Excel skills, including tables, formulas, and data analysis. 

• Experience with Pfizer systems such as PDOCS and QMS, including activities such as document editing, and training creation.  

• Experience with Ariba or other procurement systems. 

• Experience supporting audits, inspections, or interactions with regulatory agencies. 

• Experience reviewing, reconciling, or maintaining accountability records. 

• Familiarity with DEA and state controlled substance requirements is preferred. 

PHYSICAL/MENTAL REQUIREMENTS

• Ability to perform work requiring accuracy, attention to detail, and critical thinking. 

• Ability to review and analyze records, data, and documentation and identify discrepancies requiring additional investigation or escalation. 

• Ability to organize and prioritize multiple activities while adapting to changing business needs and deadlines. 

• Ability to exercise sound judgment within established procedures and seek appropriate guidance when situations fall outside established requirements. 

• Ability to communicate clearly and professionally, both verbally and in writing, participating in cross-functional discussions. 

• Ability to work both independently and collaboratively in a regulated environment. 

• Position may require sitting, standing, walking, performing detailed computer-based work, and presenting information to stakeholders. 

OTHER JOB DETAILS

• Last Date to Apply for Job: November 16, 2026
• Additional Location Information: NA
• Eligible for Relocation Package – NO
• Secondment 9-12 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).
• Note: This secondment offers a valuable opportunity for professional growth. It will need to be funded by the secondee’s home market.

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.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Regulatory Affairs