Sr Associate Scientist - Standards & Controls

Use Your Power for Purpose
The position will support the Pfizer Sanford, NC Quality Operations department by performing activities supporting standards & controls and continuous improvement projects. At a minimum, the position should be able to execute work independently, work with various groups across the organization and be able to lead investigations utilizing operational excellence tools and techniques. Key responsibilities are performing GMP tasks associated with maintaining compliant Quality Control and Stability laboratories; analyzing, interpreting, and trending results; and creating, reviewing and approving documentation.
The individual should be able to demonstrate the following:

• Acting safely, knows and follows all Environmental Health and Safety requirements for site and QC laboratories; leads safety initiatives and encourages others to act safely.
• Recognized as a "go-to" person or Subject Matter Expert for a specific subject area and are considered capable of supporting documentation management, reviewing content to ensure compliance to regulations and Pfizer policy and standards.
• Excellent effective written and verbal communication and interpersonal skills; established relationships within business lines.
• Ability to identify issues, presents complex problems with possible solutions, and actively takes leadership role to resolve of issues.
• Applies discipline's principles, appropriate procedures, and leadership skills to action plan and contribute to executing toward team/project goals.
• Method 1, yellow belt trained and can apply tools to solve issues (including technical issues).
• Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development.
• Consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail-oriented behavior.
• Good judgment and correct decision making based on Pfizer procedures, policy, and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations; decision impact awareness on future quality and compliance as well as impact on own work group, department, and network.
• Represents Quality Control on site and network teams/forums that support sustaining or improving site or network operations; influences and negotiates with business lines and shares information obtained with team; acts as change agent for improvements.
• Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule.
• Delivery on high business impact projects/activities/changes.
• Able to identify and seek out external resources to build or enhance understanding of documentation concepts/improvements and compliance; supports training of staff; mentoring and coaching junior colleagues.

What You Will Achieve

• Responsible for knowing, understanding, and acting in accordance with Pfizer's values.

• Performs tasks associated with maintaining cGMP compliant process for QC.
• Perform documentation management for QC Labs and related areas, including:
• Tracking document requests.
• Assessment of document to current standards including current site document templates.
• Author support.
• Collaboration with Doc Control, Training, and QA to approve documents.
• Support regulatory audits, as required.
• Provide expertise for troubleshooting and resolution of issues related to business processes, equipment, facilities, utilities, and human performance.
• Assess potential impact of changes to qualified systems resulting from investigational CAPAs.
  Identify and implement documentation best practices to continuously improve the site performance.
• Represent QC on site or network teams as necessary.
• The position requires execution and management of multiple initiatives at the same time and good communication skills to keep customers, peers, and area management up to date with progress of all such efforts.
  Responsible for reporting issues to management and participating in issue resolution.
• Serve on cross functional teams to represent Quality Control and facilitate communications and activities/projects between Quality Control and site departments and/or Network.
• May initiate, manage projects/changes to accomplish change activities/project deliverables and/or whole projects; responsible for prioritization and associated timely completion of activities/deliverables and/or project timelines.
  Trains junior colleagues and may develop training plans and/or oversee training activities.
• Responsible for assessing existing QC situations and suggesting continuous improvements to increase compliance and innovation.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 3 years of experience; OR a master's degree with 0+ years of experience.

• Manufacturing, quality or engineering experience in the biotech or pharmaceutical industry.
• Understanding of cGMP and Safety regulations.
• Strong organizational and communication skills.
• Team based collaborative problem solving.
• Strong understanding of cGMP, Data Integrity and ALCOA principles.
• Experience with project management.

Physical/Mental Requirements

• Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets.
• Intellectual capability to perform complex mathematical problems and perform complex data analysis.

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 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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Quality Assurance and Control