9 days old

QC Scientist III, Lead Investigator

Andover, MA 01810
**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.

**Role Summary**

The Andover Quality Control Microbiology group is looking for an individual to fill a Lead Investigator position within the department. The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports utilizing advanced technical writing skills. Duties of this position may also include coaching and mentoring to staff members, support for audits, trending of department investigations and continuous improvement activities.

**Role Responsibilities**

The candidate will be responsible for performing thorough, detailed and timely investigations related to laboratory operations and for the generation of high-quality laboratory related investigation reports.

This individual will be expected to develop collaborative relationships with the laboratory, quality, and other supporting groups in order to facilitate investigations using continuous improvement techniques. The incumbent will be expected to have experience in the area of quality and compliance and a working knowledge of GMPs. Experience with and in depth understanding of laboratory operations and various microbiological testing techniques is required. The candidate will be expected to work with a cross-functional team in defining and improving the approach towards tools used for investigations to meet changing business needs.

Additional responsibilities and expectations include:

+ Experience with the investigation process including deviations as it applies to laboratory issues.

+ Expertise in the ability to project management timelines/develop milestones, preferred experience in the use of various project management tools to ensure adherence to timeline requirements.

+ Capable of interpreting guidance/regulations and their applicability to unconventional situations.

+ Ensure investigations are conducted with a strict adherence to appropriate quality and compliance standards.

+ Ability to coordinate and facilitate meetings and lead conversations.

+ Work under limited supervision after appropriate training, with the ability to problem solve, manage priorities, and make decisions independently.

+ Support internal and external audits, regulatory queries and/or network related initiatives as related to investigations.

+ Contribute to a continuous improvement culture within the group using continuous improvement tools.

+ Promote adherence to root cause analysis and human error reduction tools.


+ Bachelor's Degree in Biology, Microbiology, Chemistry, or related scientific discipline with a minimum of 6 years of applicable laboratory experience OR MS in Biology, Chemistry or related scientific discipline with a minimum of 3 years of applicable laboratory experience.

+ Extensive knowledge and practical application of relevant microbiology (i.e. bioburden and endotoxin) techniques.

+ Strong technical writing skills, including investigations.

+ Experience with cGMPs and regulatory guidance.

+ Demonstrated leadership skills in decision making, planning and prioritization with a focus on team success in meeting defined metrics and timelines.

+ Proficiency with computer systems (Microsoft Office applications, LIMS, Trackwise, etc.)

+ Excellent verbal and written communication skills.


+ Experience with six sigma methodologies.


+ Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (laboratory, suites, etc.).


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

**Additional Job Details:**

+ **Last Date to Apply for Job: 01 MARCH 2021**

+ Referral Bonus Eligible


**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



Posted: 2021-02-17 Expires: 2021-03-19

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QC Scientist III, Lead Investigator

Andover, MA 01810

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