Tamara Pittman
Rocky Mount,NC
Summary
Pharmaceutical professional offering 28 years of experience in a GMP FDA regulated industry. Knowledge of general regulatory and cGMP requirements within the pharmaceutical environment, including Batch Formulation, Batch Record Quality, Manufacturing Investigations, Finishing Operations, Compliance & Auditing, etc. Solid multi-tasking skills, communication skills, proficient at building and maintaining professional relationships, etc. Collaborative and team-oriented with excellent communication and interpersonal skills to foster strategic partnerships and promote company reputation. Obtained a Bachelor of Science Degree in Business Administration and Organizational Administration from N.C. Wesleyan College.
Overview
17
17
years of professional experience
Work History
Senior Associate, MQA
Pfizer
11.2023 - Current
- Evaluate and review Pfizer’s clinical and commercial batches of drugs
- Ensure that product and process documents match the specifications based on established sampling and statistical process control procedures.
- Initiate, review, and approve deviations
- Provide quality leadership to cross functional teams to meet and exceed timelines
- Monitor and Perform housekeeping and GMP walkthroughs of facility
Compliance Coordinator
Pfizer
01.2022 - 10.2023
- Responsible for activities involved in developing and maintaining quality programs, processes, and procedures that ensure compliance with established standards and agency guidelines.
- Interface with site departments in coordination of audit planning and post audit activities; including but not limited to fulfilling pre-requests, scheduling, evaluation of robustness of responses and CAPAs received from departments and submitting responses to agency/customer.
- Participates in regulatory inspections, assessments, and customer audits, as appropriate
- Support Commitment Tracking Model of CAPA Management system, including initiator, Responsible Person, and/or Approver of records
- Actively participates in continuous improvement initiatives to align with business strategies
- Supports Inspection Readiness Program
- Supports preparation, revision, and implementation of relevant SOPs
- Supports all compliance responsibilities
Manufacturing Quality Investigator
Pfizer
11.2019 - 12.2021
- Completes manufacturing investigations related nonconformances to identify root cause and effective Corrective and Preventive Actions (CAPA)
- Gathers/Reviews batch records, data reports, engineering studies, training records, lab results, validation reports, equipment logbooks, to detect and assist in correcting plant issues
- Conducts interviews and collaborates with line personnel, area managers, site quality, process engineering, site security, and 3rd party vendors to develop process maps and drive root cause analysis
- Performs production walkthroughs and leads cross-functional meetings to gather insight into various methods/processes
- Writes robust formal investigation reports that include detailed process overviews, incident descriptions, root cause analysis, suggested CAPAs, and recommend disposition
Batch Record Quality Auditor
Pfizer
04.2018 - 10.2019
- Responsible for review and/or final release of filled and or finished package product (Pharma/Device) for commercial distribution domestic and internationally
- Responsible for conducting technical quality and compliance reviews and/or final release in accordance with current Good Manufacturing Practices (CGMPs), FDA regulations and Standard Operating Procedures (SOPs)
- Made sound decisions to ensure quality compliance and all procedural requirements are met for approval/rejection of each lot
- Reviewed batch records for cGMP compliance, Good Documentation Practices and FDA regulatory requirements in order to approve/reject finished drug product for commercial distribution
- Ensured all documents were present as issued by Index Sheet. Ensured all blanks contain appropriate data. Verifies all accountability calculations
- Verified all Commodities, Active Pharmaceutical Ingredient (API), materials, and packaging components materials used are accurate and correct
- Ensured temperature requirements and processing specifications are met throughout manufacture/packing of batch Reviews Line personnel records for correctness and accuracy
- Verified all associated batch tickets and charts are present and accurate. Reports on batch deficiencies as noted during review that may delay batch release and consults with supervision or management on decisions for all issues
- Assured that all documents received in batch release area are reviewed for completeness and accuracy
Manufacturing Compliance Technician
Pfizer
12.2014 - 04.2018
- Reviewed R1 SVP Solutions batch records for cGMP Compliance, Good Documentation Practices, and FDA regulatory requirements
- Assured that all completed documents received in SVP Solutions Manufacturing Department were reviewed for completeness and accuracy
- To ensure audit/inspection readiness, led area walkthroughs frequently in SVP Solutions Department to ensure area to be inspection ready; identifying non-compliant events.
- Assisted in creation/completion of actions needed to resolve non-compliant events identified during walkthroughs
- Aided in revision of departmental SOP's and batch records
Production Technician/SVP R1 Solutions
Hospira Inc.
04.2007 - 11.2014
- Formulated solutions based upon work order procedures
- Performed mathematical calculations
- Performed critical measurements and weighing of raw drugs
- Completed accurate and timely documentation to comply with FDA and cGMP regulations
- Worked closely with R&D and Validation teams for support of area functions
- Used independent judgement sometimes in decision making
Education
Bachelor of Science - Business Administration/
NC Wesleyan University
Rocky Mount, NC12.2017
Skills
- Pfizer Global Quality Tracking System certified
- Completed Pfizer Method 1 Training/Yellow Belt certified
- Knowledge of current Good Manufacturing Practices
- Effective communication
- Adaptability/Flexibility
- Team Building
- Work Ethic
- Integrity
- Time Management
- Multitasking
Timeline
Senior Associate, MQA
Pfizer
11.2023 - Current
Compliance Coordinator
Pfizer
01.2022 - 10.2023
Manufacturing Quality Investigator
Pfizer
11.2019 - 12.2021
Batch Record Quality Auditor
Pfizer
04.2018 - 10.2019
Manufacturing Compliance Technician
Pfizer
12.2014 - 04.2018
Production Technician/SVP R1 Solutions
Hospira Inc.
04.2007 - 11.2014
Bachelor of Science - Business Administration/
NC Wesleyan University
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