Quality Operations Drug Product: Associate

Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver is of the highest standard. Your role is crucial in maintaining this commitment and driving forward our mission to improve patient outcomes.
This Quality Operations (OQ) position will support the Groton, CT PharmSci Small Molecules QO department by assisting in quality operations activities related to the manufacture and disposition of GMP clinical Drug Product. As an Associate Operations Quality colleague, the successful candidate will have quality touchpoints prior to the start of drug product manufacturing through disposition of final drug products for clinical use. Paramount to this role will be acting as a quality point of contact for supporting investigations and ensuring compliance with regulatory and internal standards.
This role does not oversee direct reports.
This role will offer the opportunity to collaborate with partner lines across Pharmaceutical Sciences Small Molecule (PSSM), as well as with other groups within PSSM Operations Quality.
This is a great opportunity for someone to join the Quality Operations team with quality oversite to PSSM drug product manufacturing in Groton CT.
What you Will Achieve

• Support for internal Groton CT drug product manufacturing, including quality touchpoints in cleaning validation, master batch records, working batch records, review of executed batch records and final bulk material disposition.
• Help in handling the disposition of clinical Drug Product and intermediates, in support of Groton GMP manufacturing and testing operations, including partnering with key PSSM business lines
• Review/Approve quality records such as investigations, and commitments.
• Support compliance and inspection readiness activities.
• Support documentation life cycle activities.
• Collaborate with OQ and business-line partners to ensure local processes and quality systems are in alignment with global procedures, internal quality standards, and regulatory requirements.
• Contribute to the development and compliance of OQ and business line partner standard operating procedures via authoring, reviewing and approval of Standard Operating Procedures
• Identify opportunities and facilitate continuous improvement solutions to ensure consistency, compliance, and best practice sharing.
• Ensure appropriate networking to develop and maintain close and effective business partner relationships with colleagues.
• Ensure adherence to regulatory and internal compliance standards.
• Support documentation life cycle activities such as procedure administration and/or active library activities.

Soft Skills Required:

• Good interpersonal, organizational, and communication skills (both oral and written) and demonstrated skills in team matrix working.
• Proven ability to deliver technical reports/presentations.
• Strong demonstrated learning and change agility.
• Ability to innovate new, novel solutions to both new and old problems.

Here Is What You Need
(Minimum Requirements)

• Applicant must have a bachelor's degree with 0+ years of experience; OR
  an associate's degree with 4 years of experience; OR a high school
  diploma (or equivalent) and 6 years of relevant experience
• Ability to handle multiple tasks concurrently and in a timely manner.
• Excellent written and verbal communication skills.
• Advanced computer skills in MS Office applications and good knowledge of enterprise systems.

Bonus Points If You Have
(Preferred Requirements)

• Relevant work experience in a cGMP pharmaceutical manufacturing, testing and or OQ environment
• Experience with handling GMP compliance issues, resulting from GMP deviations or material/product defects, and participation in quality investigations
• Experience in quality assurance is strongly desired
• Hands-on knowledge of systems such as GDMS, eQMS, EMD, QTS, and LIMS

Non-Standard Work Schedule, Travel or Environment Requirements
Support of off shift (i.e. non-core hours) when necessary, which would require flexible working hours.
Work Location Assignment: On Premise Groton CT
The annual base salary for this position ranges from $66,500.00 to $110,900.00. 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.
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.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [email protected] . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
Quality Assurance and Control