Sr. Associate, Instrument Systems And Compliance

Pfizer Andover , MA 01810

Posted 2 months ago

ROLE SUMMARY

  • This role is responsible for the support of analytical instrumentation lifecycle needs in accordance with established SOPs, regulations, and Quality Standards following cGMP principles. This role will develop, execute and deliver validation services and documentation necessary to qualify and maintain analytical systems under Pfizer requirements and current regulations. Excellent written and communication skills, effective time-management, an innovative spirit, and the ability and desire to work both independently and collaboratively in a multidisciplinary, fast-paced, team-oriented environment are essential for the position.

ROLE RESPONSIBILITIES

  • Execute IQ/OQ/PQ activities, data integrity assessments, and other lifecycle requirements for GMP analytical instrumentation including documentation following cGMP expectations.

  • Onboard new GMP analytical instruments and equipment.

  • Provide change control support of GMP analytical instrumentation, equipment, systems, and associated services.

  • Support administrator and periodic review needs for GMP instruments.

  • Stay current on Good Manufacturing Practices (cGMPs) guidelines, Good Laboratory Practices (GLPs), and exhibiting best practices within manufacturing, testing, safety, compliance, investigations, and procedures.

  • Create and follow SOPs as required to support activities in a cGxP environment

  • Support projects to onboard appropriate instrumentation.

  • Communicate with customers as necessary in order to progress work in a timely and appropriate fashion.

  • Perform duties in a safe manner with a focus on Zero Injuries.

  • Lead and/or participate in continuous improvement activities, including DI remediation.

  • Specific PPE requirements, including clean room gowning, may be required.

BASIC QUALIFICATIONS

  • Minimum of BS degree in Biology, Chemistry, or related field plus 4 years experience in a GMP laboratory or similar field.

  • Experience in GMP QC laboratory, including trending of data, investigation management, and working in a regulated environment is required.

  • Able to work in a fast paced team environment with changing priorities

  • Excellent documentation skills

  • Experience with UV, HPLC, pH, Bioburden, Endotoxin, PCR, and other similar laboratory instrumentation and methodologies

PREFERRED QUALIFICATIONS

  • Self-motivated and highly effective in a team-based environment

  • Effective oral and written communication skills

ADDITIONAL OFFER DETAILS

  • Additional Location Information: Andover, MA
  • Eligible for Employee Referral

    Bonus:
    Yes

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.

N (Other) (United States of America)

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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Sr. Associate, Instrument Systems And Compliance

Pfizer