ROLE SUMMARY
Reporting to the Quality Operation Manager – Validation Support, the Senior Quality Operations Specialist - Validation Support will:
Lead day-to-day Quality Operations support of validation activities and timelines for manufacturing, lab equipment, computer systems, spreadsheets, and other computer system/automation processes to ensure the validation activities are performed in compliance with Good Practice (GxP) principles, regulatory requirements, and Pfizer policies and standards.
Lead and contribute to cross-functional teams in driving compliance improvements/initiatives that are innovative and risk-based, to quality systems.
Lead the completion of periodic reviews for validated systems.
Provide day-to-day support for new Master Data, and updates to Master Data.
Provide day-to-day support for LIMS activities.
Receive guidance and coaching from Quality Operations manager as needed and follow direction/approval of activities and decisions.
ROLE RESPONSIBILITIES
Lead Quality Operations site validation projects by reviewing and approving validation documents and deliverables comply with Good Manufacturing Practice (cGMP), regulatory requirements, company policies, and standards.
Review and approve executed periodic review protocols.
Draft, update, review, and approve Standard Operating Procedures (SOPs).
Engage inter-department colleagues and lead cross-functional teams from Manufacturing, Engineering, Technical Services/Validation, Laboratory, Business Technology (BT), and Automation on a regular basis.
Support audits and inspections (Pre/During/Post) for all requested documents.
Review and approve new Master Data and process changes to existing Master Data of varying technical complexity and master data updates for Change Controls.
Provide troubleshooting expertise and aid in interfacing with site personnel while supporting all LIMS activities and end users including instrument interfaces in conjunction with the BT Department and integration of sample management and electronic system processes to ensure optimal business processes.
Lead the completion of project tasks influencing the immediate work team and cross-functional teams and participate in all required meetings to support LIMS, Master Data, and Validation activities.
Contribute to and lead moderately complex projects in a cross-functional team structure.
Make decisions to resolve moderately complex problems with short-term and long-term impact within cross-functional teams.
Exercise judgment under minimal supervision.
Actively engage in personal development, including growth plans, and any training or assignments from the Quality Operations Manager – Validation support.
Ensure training is maintained and in compliance with appropriate procedures, specifications and standards.
Build and lead strong collaborative relationships with site validation colleagues.
BASIC QUALIFICATIONS
· Applicant must have a bachelor's degree with at least 2 years of experience; OR a master’s degree with more than 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years of relevant experience.
· Experience in the pharmaceutical and/or manufacturing industry, preference in documentation, Quality, and/or Quality Systems (eQMS, QTS, PDOCs, EDES, etc.).
· Ability to communicate effectively across diverse functional groups and layers of management.
· Strong Technical writing skills.
Strong verbal and written communication skills.
Ability to work in a team environment, contribute to and manage projects independently with minimal manager oversight.
Able to collaborate and partner cross-functionally.
Strong working knowledge of a variety of quality systems and processes.
Relevant pharmaceutical knowledge.
LIMS/SAP and Application Lifecycle Management Quality Center (ALM-QC) experience.
Knowledge of Quality Systems Business processes, Master Data processes and Laboratory/Sample Management processes.
Strong working knowledge of electronic systems including, but not limited to, PDOCs, PLOGs, MS Word, Excel, KNEAT (EDES), and MS Office.
· In depth knowledge and understanding of GxP regulations and Quality System requirements as per 21 CFR Part 58, 21 CFR Part 11, Annex 11, 21 CFR Part 210 and 211, 21 CFR 820, and other applicable regulations.
PREFERRED QUALIFICATIONS
· In-depth understanding of computer system validation and equipment qualification concepts, including hands-on validation experience.
· In depth understanding of automation and programming.
Expert proficiency with all quality standards and compliance requirements.
PHYSICAL/MENTAL REQUIREMENTS
PHYSICAL/MENTAL REQUIREMENTS
· Ability to stand for 1 hour a time, sit for 2 to 3 hours a time. Require working in an office setting where sitting and computer usage would be typical.
· Acute mental and visual attention at all times
· Requires moderate lifting or moving up to 25 pounds (lbs)
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
• Work Location Assignment: On Premise
• Requires regular onsite attendance
• Must have the ability to work effectively under strict deadlines
• Must be able and willing to work beyond office hours which may include weekends and holidays
• Must be capable of supporting up to 10% travel (domestic and international)
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.
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