QC Associate Scientist

Role Summary:

The position will support the Pfizer Sanford, NC Quality Operations department by performing Quality Control activities associated with clinical and/or commercial product, raw materials, validation, and stability. Key responsibilities are performing GMP tasks associated with maintaining and operating compliant Quality Control and Stability laboratories; receiving samples to the laboratories for testing, shipping samples to off-site laboratories for testing, entering and/or reviewing off-site laboratory test results in the Laboratory Information Management System (LIMS) and/or other data systems, ordering/receiving/stocking lab supplies, operating autoclaves and glass washers, managing media supply, disposing/documenting expired reagents, reagent preparations and other tasks related to the operation of the Quality Control labs. The position is a support function to the Quality Control labs and requires none or very minimal non-complex analytical lab testing. Participating in investigations of events/OOS; acting as a change agent and driving Continuous Improvement/Operational Excellence/innovative implementations; representing Quality Control on cross functional teams; leading projects and/or teams and providing guidance/training/coaching to junior colleagues.

The individual should be considered able to demonstrate the following:

• Acting safely, knows and follows all EH&S 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 is considered capable of supporting audits and investigations, reviewing/approving technical content to ensure scientific merit and 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
• Solving complex mathematical problems and situation dependent problems using convoluted information
• 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 (e.g. PDA, ISPE) to build or enhance understanding of scientific discipline; supports training of staff; mentoring and coaching junior colleagues
• Expertise with investigations quality system and able to independently handle complex investigations and associated CAPA within own work area under limited guidance
• Capability of detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes

Individual should have knowledge of US, EU, and cGMP; pharmacopeias; ICH guidelines; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWiseTM application); Microsoft Office™ applications specifically Word, Excel, and PowerPoint; Lean Six Sigma concepts; Lean Labs; project management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments.

Role Responsibilities:

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

Primary function of the job: This position reports to the QC Lab Support group at the Pfizer Sanford, NC site. The QC Lab Support group supports all Quality Control laboratories such as but not limited to Chemistry, Microbiology and Bioanalytical. Knowledge of the operation of a cGMP Quality Control laboratory is preferred.

In addition, may be asked to perform tasks associated with maintaining and operating cGMP compliant Quality Control and Stability laboratories such as but not limited to:

• Laboratory and CTU cleaning, pH meter standardization and balance verification
• Manage off-site laboratory testing and result transcription in LIMS
• Prepare, label vials, and aliquot samples, standards, controls and critical reagents
• Assist Quality Control analysts with the preparation of buffers, HPLC mobile phases, reagents and media
• Responsible for appropriate creation, review and approval of cGMP documentation (test methods, equipment records, etc.) and ensuring adherence to Pfizer standards, guidelines and values
• Responsible for reporting issues to management and participating in issue resolution (such as reporting events and participating in laboratory investigations, reporting instrument issues, and assisting with troubleshooting, etc.)
• Assess existing situations and suggesting improvements to increase compliance and innovation
• Responsible for appropriate creation, review, approval and final authorization of GMP documentation (test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values
• Responsible for detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes
• Responsible for reporting issues to management and participating in issue resolution (such as reporting OOS results and participating in associated laboratory investigations, reporting instrument issues and assisting with troubleshooting, etc.)
• Responsible for contributing to and/or handle laboratory investigations for events and OOS results
• Train junior colleagues and may develop training plans and/or oversee training activities for groups
• Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation

May perform data trending activities and assist with metrics reporting.

May initiate, lead a working group and/or 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.

May serve on cross functional teams to facilitate communications between Quality Control and other departments.

Qualification Requirements:

• 2-5 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry
• A BS/BA Degree in Science/related field with experience in biotech or pharmaceutical industry is preferred; however, other appropriate combinations of education and/or experience in the biotech or pharmaceutical industry are suitable

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 mathematical problems and perform data analysis.

Work schedule may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities. Limited travel for the position; no more than 10% traveling.

• Last Date to Apply for Job: 13 October, 2020
• Eligible for Employee Referral Bonus

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.

Quality Assurance and Control