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Sr QA Specialist

Pfizer


Location:
Groton, CT
Date:
11/18/2017
2017-11-182017-12-19
Pfizer
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Job Details

**ROLE SUMMARY**



The colleague in this role will







+ Support and maintain quality systems such as laboratory investigations, deviation management, corrective and preventive actions (CAPAs), notification to management, instrument qualifications and change management system.



+ Ensure quality systems are maintained consistent with cGMPs, Pfizer policies, site procedures and regulatory guidance.



+ Review and approve from a quality perspective, various types of laboratory documentation according to procedure requirements.



+ Review and Release Certificates of Analysis following certification of reference standards.



+ Provide oversight for administration of the training and document management systems.







**ROLE RESPONSIBILITIES**







+ Provide quality oversight to ongoing laboratory investigations and deviations. Apply relevant analytical experience to solve technical problems in order to partner with the laboratories to identify root cause. Ensure that laboratory investigation reports and deviation reports are investigated, the information documented with sound scientific justification, adequate impact assessments are provided, appropriate root cause identified, meaningful correct/preventive actions proposed as established in the current procedures.



+ Review/approve various types of laboratory documentation. These documents would include (but are not limited to) laboratory investigation reports, deviation reports, analytical method validation protocols and reports, analytical method transfer protocols and reports, change control documentation, reference standard protocols, certificates of analysis, laboratory instrument qualification/calibration, laboratory procedures, memorandums and quality alerts according to procedure requirements.



+ Author and distribute Quality Notification Reports to customers.



+ Ensure site quality systems are consistent with cGMPs, Pfizer policies, site procedures and regulatory guidance.



+ Contribute to quality assurance management team initiatives and objectives.



+ Work together with the SLS management to assure that objectives and metrics are met.



+ Create, track and approve corrective/preventive action items to help ensure they are completed within the agreed timeframes.



+ Perform internal/external audits as needed and provide timely feedback during the audit process. Assure adequate follow-up and resolution of external or internal audit findings



+ Support external audits of SLS through activities such as scribing, and coordinating document retrieval/review.



+ Participate in the SQRT process.



+ Communicate with other Pfizer sites and suppliers/ contractors external to Pfizer to support business processes and to benchmark on best







QUA **LIFICATIONS**







+ Education: Bachelor's degree or higher in Chemistry or related discipline.



+ Experience: 5-7 Years of related analytical chemistry experience with a Bachelor's degree or 3-5 years of related analytical chemistry experience with an advanced degree. This experience should include authoring/approving analytical investigations and deviations.



+ Experience with electronic laboratory systems (gQTS, LIMS, PDOCS) preferred.



+ Experience with Pfizer Human Performance (PHP), Lean Laboratory and Risk Management is highly desirable.



+ QC/QA experience in a drug product or API manufacturing environment is desirable.







**PHYSICAL/MENTAL REQUIREMENTS**







+ Excellent written and oral communication skills with the ability to summarize complex situations in an easily understandable narrative.



+ Must be comfortable interacting with all levels of management in the PGS organization.







**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS**







+ Ability to travel an estimate of 5-10%.



+ Some over time and weekend support may occasionally be required.







**ORGANIZATIONAL RELATIONSHIPS**







Internal Pfizer Contacts:



Within SLS - Will interact with all positions and levels



Outside SLS - Global Functional groups including PGS, Global Quality, GMS, GCMC, APQA, GES, Supply Chain, with other Pfizer leaders & technical groups.







External Contacts:



Will interact with outside regulatory agencies during external audits







**RESOURCES MANAGED**



None







**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.







**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.







**Additional Offer Details:**







+ Last Date to Apply for Job: December 1, 2017



+ This job is Pfizer/Exempt (US/PR) Grade: 07







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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