Sr. Quality Compliance Specialist
Location
Rocky Mount, NC | United States
Job description
Why Patients Need You
Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you'll help bring medicines to the world even faster by imagining what's possible and taking action.
What You Will Achieve Working with Pfizer's dynamic engineering team, you will play a critical part in providing technical or business support to engineers on a variety of technical tasks. Your documentation skills will come in handy to prepare engineering documentation, reports and drawings.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
It is your dedication and hard work that will make Pfizer ready to achieve new milestones and help patients across the globe.
The primary function of this position is quality compliance support the aseptic manufacturing areas in R3. The Sr. Quality Compliance Specialist is responsible for supporting the planning, execution, tracking, and completion of key aseptic related projects such as but not limited to: PQS implementation, shut down/restart process, media fill oversight, investigation and change management impacting the classified areas. This candidate must be able to work cross functionally with Operation, Maintenance, Validation, Process Engineering and MQ to deliver key milestones for projects.
How You Will Achieve It - Responsible for supporting the smoke study and media fill programs for R3.
- Responsible for conducting and writing formal investigation reports impacting the classified areas.
- Responsible for implementing improvements to the classified areas, such as those derived from Annex 1 and contemporization of the manufacturing facilities.
- Ensures the execution of media fills matches commercial operation in alignment with proper aseptic technique.
- Performs impact risk assessment for changes impacting the classified areas.
- Develop and implement necessary remediations to minimize the risk to product manufactured.
- Track, implement and close CAPAs for Environmental Control.
- Utilize change management systems to implement improvements impacting the classified areas, including documents and procedures updates.
- Liaise with departments such as Process Engineering, Manufacturing and Manufacturing Quality as required to meet project deadlines.
- Perform necessary assessments of aseptic operation with partnership for corporate SMEs. Develop and own projects to remediation necessary gaps.
- Responsible for working with Corporate SMEs to ensure compliance with PQS and regulatory expectations.
- Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to aseptic manufacturing.
- Develop and coach R3 operations on aseptic practices.
Qualifications Must-Have - Requires Bachelor's Degree in a technical field, such as Engineering with 3+ year experience pharmaceutical quality environment required
- Or, Master's Degree in a technical field, such as Engineering with 1+ year experience pharmaceutical quality environment required
- Requires thorough knowledge of GMP's and understanding in aseptic processing
- Must have the ability to handle multiple projects in a dynamic environment
- Must be self-directed and requires an appropriate level of education and experience to make and act upon decisions that impact the site from an sterile manufacturing standpoint
- Pharmaceutical operations experience and/or knowledge is required
- Working knowledge of FDA regulations
- Knowledge of various quality tools, such as investigation process, change management, etc
- Excellent facilitation skills and ability to facilitate strategy meetings
- Superior technical writing and problem-solving skills
- Organize data, extract key information and write technical protocols and reports
- Ability to interface with multiple levels of people in the organization, including plant personnel, senior management and corporate officials
- Must be able to present study to regulatory agents with simplicity and confidence
- Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis
- Mustbe able to work on weekend, off shifts and holiday as business demands
- Must be able to work in a team setting and willing to lead others
Nice-to-Have - Experience in the Pharmaceutical or Biotechnology industry
PHYSICAL/MENTAL REQUIREMENTS Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition, must be able to appropriately identify and escalate issues on a timely basis.
Must be able to consistently aseptic gown.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Must be able to work on weekend, off shifts and holiday as business demands.
Work Location Assignment: On Premise
The annual base salary for this position ranges from $78,000.00 to $130,000.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% 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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