Quality Control Raw Materials Sampling Associate

Regulatory Toolkit; Andover (MA); On-site; USD 60,000 - 100,000; Full time

Benefits offered by this job

401(k) match

Retirement savings contribution

Health benefits

Paid time off

Job summary

Regulatory Jobs in Andover is seeking a QA/QC position focused on GMP sampling and analytical testing of raw materials. The role involves performing sampling, testing, documentation, and participation in continuous improvement activities within the QC Analytical Department.

The ideal candidate has a degree with GMP lab experience or equivalent, strong cGMP knowledge, and proficiency with LIMS and Microsoft Office. First shift, on-site work with potential off-hours support.

Qualifications

• Bachelor's degree with any years of experience, or an associate's degree with 4 years of relevant experience, or a high school diploma with 6 years of relevant experience.
• Experience performing QC analytical testing and following procedures in a GMP laboratory.
• Strong understanding of cGMP regulations.

Responsibilities

• Perform Raw Material Sampling in the GMP warehouse to support clinical and commercial manufacturing operations.
• Perform Daily Sanitization of ISO classified Sampling Areas.
• Perform and Review Appearance, Gas, and Raman Spectroscopy testing on Raw Materials.
• Record and maintain data and records in compliance with cGMP and quality procedures.
• Work to ensure safety policies are followed and participate in site culture programs.

Skills

QC analytical testing

GMP laboratory procedures

cGMP regulations

LIMS proficiency

Microsoft Office

Data recording

Education

Bachelor's degree

Associate degree

High school diploma

Tools

Labware LIMS

Job description

Use Your Power for Purpose

The Quality Control Analytical group is seeking a highly motivated candidate to support GMP sampling and analytical testing of raw materials at the Andover site. The candidate will perform sampling, testing, and support activities for raw materials, attend meetings, and participate in continuous improvement activities.

What You Will Achieve

In this role, you will:

• Perform Raw Material Sampling in the GMP warehouse to support clinical and commercial manufacturing operations
• Perform Daily Sanitization of ISO classified Sampling Areas
• Perform and Review Appearance, Gas, and Raman Spectroscopy testing on Raw Materials.
• Participate in continuous improvement culture within sampling areas. Identify opportunities for improvements and utilize site continuous improvement tools.
• Plan and prioritize assignments to meet department and site goals
• Record and maintain all related data and records in compliance with cGMP and quality procedures.
• Perform work in a manner consistent with company safety policies and procedures.
• Participate in company culture based programs.
• Perform additional tasks as needed in the QC Analytical Department

Here Is What You Need (Minimum Requirements)

• Bachelor's degree with any years of experience, or an associate's degree with 4 years of relevant experience, or a high school diploma (or equivalent) and 6 years of relevant experience
• Experience performing QC analytical testing and following procedures in a GMP laboratory
• Strong understanding of cGMP regulations
• Proficiency with computer systems (Microsoft Office applications, LIMS, etc.)

Bonus Points If You Have (Preferred Requirements)

• QC laboratory experience includes Raman Spectroscopy testing
• Experience with sampling raw materials for GMP operations
• Experience with GMP industry standards as applied to raw materials
• Experience with Labware LIMS PREFERRED QUALIFICATIONS

PHYSICAL/MENTAL REQUIREMENTS

Lifting up to 50-100 pounds daily. 5 to 8 hours walking, lifting, moving materials in the warehouse. Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required to support staff and operations.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required to support staff and operations.

Other Job Details:

• Work Location Assignment:On Premise
• Last Day To Apply: November 12th

The annual base salary for this position ranges from $60,200.00 to $100,400.00. 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.

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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Quality Assurance and Control