Environmental Monitoring Team Lead

Why Patients Need You.

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve.

In this position, you will be a member of Pfizer’s dedicated and highly effective Quality Control Team. You will be responsible for leading and coordinate the activities of a team of Biological Quality colleagues responsible for the site Environmental Monitoring (EM) Program. The program includes monitoring for bioburden and particulate within all manufacturing areas and the site utility systems.

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 teaming environment for your colleagues.

It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It.

• Provide lab leadership and coordination for a team of overtime eligible colleagues that are responsible for the site Environmental Monitoring (EM) program. In coordination with EM Supervisor, reviews performance of team members.
• In coordination with EM Supervisor, lead department tasks, scheduling, projects, programs, training, and laboratory in accordance with Good Manufacturing Practices (cGMP) procedures, Good Laboratory Practices (cGLP) procedures, regulatory requirements, and company policies and standards.
• Maintain all aseptic and EM qualifications. Perform environmental monitoring activities as necessary to support the teams schedule and goals.
• Responsible for training of EM lab technicians in all environmental monitoring aspects.
• Ensures actions in relation to deviations and excursions are carried out, and that testing is performed to appropriate standards.
• Responsible for ensuring EM equipment is in compliance, i.e. calibration, preventative maintenance.
• Performs technical and (GDP) Good Documentation Practice review of executed data with focal points on completeness and data integrity.
• Collaborate with other quality, support, engineering, and manufacturing departments and make technical and quality decisions regarding aseptic operations and environmental control
• Assist in maintaining department Standard Operating Procedures (SOPs), Monographs, Training Course Plans, Protocols, and Reports as a subject matter expert (SME)
• Lead or contribute on complex projects and improvement initiatives, managing own time and time of others to meet deadlines
• Provide support as a SME during regulatory inspections

Qualifications:

Must-Have

Applicant must have a HS Diploma (or Equivalent) and 6 years of
relevant experience OR an associate’s degree with 4 years of
experience OR a bachelor’s degree with 0+ years of experience.

Nice-to-Have

• Quality control or laboratory experience preferred.
• Relevant pharmaceutical industry experience preferred.
• Leadership experience preferred.
• Project management experience preferred.

PHYSICAL/MENTAL REQUIREMENTS

• Lab position with ability to sit or stand for long periods of time.
• Significant time spent in production environment utilizing PPE. Some controlled/aseptic gowning may be required
• Ability to perform mathematical calculations or data analysis.
• Ability to multi-task and work in a fast-paced environment
• Work location: Onsite premise

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Must be able to work rotating 12-hour shift including every other weekend
• Position may require some weekend, off shift, or night shift presence to support operations and site activities as business needs dictate
• Some infrequent travel may be required
• Work location on site premise

Other Job Details:

• Eligible for Employee Referral Bonus: YES
• Eligible for Relocation Assistance: NO

PHYSICAL/MENTAL REQUIREMENTS

• Lab position with ability to sit or stand for long periods of time.
• Significant time spent in production environment utilizing PPE. Some controlled/aseptic gowning may be required
• Ability to perform mathematical calculations or data analysis.
• Ability to multi-task and work in a fast-paced environment

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Night shift schedule
• Must be able to work rotating 12-hour shift including every other weekend
• Position may require some weekend, off shift, or night shift presence to support operations and site activities as business needs dictate
• Some infrequent travel may be required

Work Location Assignment:On Premise

The annual base salary for this position ranges from $62,800.00 to $104,500.00. 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 tendersglobal.net (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.

Quality Assurance and Control