Associate Specialist, Quality Assurance

Job Description

Associate Specialist Quality Systems and Compliance (P1)- day shift

Our company is expanding its global recombinant human papillomavirus (HPV) vaccine production network by investing $650 million and adding a 225000-square-foot building within the footprint of the Maurice R. Hilleman Center for Vaccine Manufacturing in Durham NC. The new facility will be used to produce the bulk active ingredient for the HPV vaccine comprised of fermentation microfiltration/ultrafiltration and chromatography steps.

Approximately 614000 people are diagnosed with certain HPV-related cancers each year. Our company manufactures the two HPV vaccines that are predominantly utilized to eradicate these cancers globally. In recent years countries around the world have enacted new or expanded HPV vaccination programs which has created an unprecedented increase in global demand. The manufacturing facility in Durham will play a critical role in the network of plants that produce life-saving medicines and vaccines including our HPV vaccines.

Description

The Quality Associate Specialist provides guidance/direction of resources and equipment pertaining to qualification/validation and start up activities supporting the HPV expansion facility working onsite day shift including weekend coverage.

GENERAL PROFILE:

• Ability to work independently and as a member of a team.
• Contributes to the performance and results of the expansion project.
• Adapts plans and priorities to address resource and operational challenges.
• Decisions are guided by policies procedures and/or business plans.
• Provides technical guidance to employees colleagues or clients.
• Anticipates and interprets client and/or customer needs to identify solutions.

FUNCTIONAL EXPERTISE:

The Quality Associate Specialist will be responsible for comprehensive management of all activities required to successfully support qualification and production to include the following:

• Responsible for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as our company policies and procedures.
• Responsible for establishing processes that ensure required safety guidelines are followed.
• Review and approve electronic logbooks and batch records.
• Review and approve documents pertaining to environmental monitoring and process qualification.
• Author review and approve SOPs.
• Assume project opportunities by leading and participating in process improvement learning events or business support initiatives as guided or approved by Quality management.
• Train employees on new or revised processes or procedures.
• Actively participates in suite team projects as required.

Other:

• Support of regulatory inspections and audits.
• Support of validation activities and all other associated Quality functions.
• Other duties as requested by Management.

PROBLEM SOLVING:

• Supports resolution of technical and operational problems through collaboration with peers.
• Applies appropriate risk management while adhering to cGMP requirements.
• Makes decisions guided by policies and procedures that impact the teams ability to meet performance objectives.

• Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes.

QUALIFICATIONS:

Required:

• Bachelors or Masters Degree in Biology Biochemistry Chemistry or other relevant discipline.
• Minimum of 1 year of experience (combined intern co-op or full time) in pharmaceutical operations technical services and/or quality operations.
• Ability to workday shift including weekend coverage and holidays.
• Demonstrates flexibility and ability to manage multiple priorities.
• Demonstrates interpersonal technical aptitude and problem-solving skills.

Preferred Experience:

• cGMP experience in a sterile bulk or finished pharmaceutical environment.
• Experience with process or environmental monitoring documentation.
• Experience with SAP electronic batch records and GLIMS.

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

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