QC Scientist III- Technical Writer

ROLE SUMMARY

The Andover Quality Control Analytical group is looking for an individual to fill an Investigator/Change Control 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.  The qualified candidate will also support the writing of change controls and project manage the change controls to completion. 

ROLE RESPONSIBILITIES
The candidate will be responsible for performing thorough, detailed and timely investigations related to laboratory operations as well as writing and managing change controls. 
 
This individual will be expected to develop collaborative relationships with the laboratory, quality, and other supporting groups to facilitate investigations and change controls. The incumbent will be expected to have experience in the areas of quality and compliance and a working knowledge of GMPs. Experience with and in depth understanding of laboratory operations and various analytical testing techniques is required.
 
 Additional responsibilities and expectations include:

• Expertise of the investigation process including deviations as it applies to laboratory issues.
• Expertise in writing change controls including strong technical writing skills. 
• Expertise in the use of various project management tools to ensure adherence to timeline requirements.
• Ensure investigations are conducted with a strict adherence to appropriate quality and compliance standards.
• Ability to coordinate and facilitate meetings, lead conversations, and influence teams.
• Work under limited supervision, with the ability to problem solve, manage priorities, and make decisions independently.
• Support internal and external audits, regulatory queries and/or network related initiatives.
• Contribute to a continuous improvement culture within the group using continuous improvement tools.
• Promote adherence to root cause analysis and human error reduction tools.
   

BASIC QUALIFICATIONS

• Bachelor's Degree in Biology, Chemistry or related scientific discipline with 5+ years of applicable  experience OR MS Degree in Biology, Chemistry or related scientific discipline with 3+ years of applicable experience required.

• Extensive knowledge and practical application of relevant analytical techniques (analytical testing and troubleshooting).

• Strong technical writing skills, including investigations and change controls.

• Experience with cGMPs, regulatory guidance and audits.

• 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.

PREFERRED QUALIFICATIONS

• Knowledge of analytical techniques including HPLC, Capillary Gel Electrophoresis, Peptide mapping and UV Spectrophotometry.

• Experience with six sigma methodologies.

• 2+ years of Technical Writing experience

• Project Management experience

PHYSICAL/MENTAL REQUIREMENTS

• Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office and in the laboratories.  Position is first shift Monday through Friday.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Position is first shift Monday through Friday. Some off hour support may be required to support priorities.

Other Job Details:

• Last Date to Apply: October 11, 2021

• Eligible for Employee Referral Bonus

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment.  As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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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

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