Job#: 1303564

Job Description:

Apex Systems is looking to hire multiple levels of Quality Specialists (I, II, and III) with a major Pharmacuetical company in the Rancho Cordova, CA area!

**For immediate consideration please send an updated copy of your resume to Megan at mmantlo@apexsystems.com and use the link below to put a call on my calendar**

https://apexsystems.sensehq.com/scheduler/9018685979178889313/15-minute-meeting

Title: Quality Specialist

Length: Direct Hire

Hours: Monday-Friday 8am-5pm

Location: Rancho Cordova

Summary:

Quality Assurance Specialist I is responsible for supporting multiple programs or supporting the coordination of the quality systems, but not necessarily both. The Quality Assurance Specialist I will be responsible for ensuring that adequate QA support is provided for the cross functional IPT meetings and customer teleconferences.

Responsibilities:

• Responsible for communicating the status of QA related items to the IPT Team including batch release and investigation status.
• Take an active role providing, as appropriate, guidance within the approved systems and procedures as it related to GMP production and release of products, some of this guidance may be required outside of the typical working schedule (off shift).
• Responsible for taking an active role in planning and execution of action items related to support of production and product release, including document control and production record review activities.
• Responsible for managing the release of products to support subsequent production and release of product to customer within the approved systems and procedures.
• Responsible for managing change controls in support of production and release activities.
• Responsible for review and/or conduct of investigations for deviations in production and testing (VAR, MNCRs, OOS/OOT investigations, QCRs).
• Responsible for ensuring process validation and qualification requirements are established in approved protocols and results of the validation and qualifications are adequately presented in approved reports. Responsible for facility audits of the respective manufacturing facilities at the start of each campaign and periodically while long running campaigns are active.
• Responsible for ensuring that reports within a given system are progressing in a manner that complies with the approved procedures and deadlines.
• Responsible for ensuring submitted reports contain adequate information and attachments/links to allow appropriate review and approval.
• Responsible for assignment and/or reassignment of appropriate personnel to the documentation, review and approval of quality systems reports.
• Responsible for the development and reporting of appropriate metrics for review by management and to obtain and maintain appropriate training for the requirements of this role.

Qualifications:

• Associates degree required.
• Bachelor’s degree (preferred) in an appropriate science.
• 0-2 years of related technical experience or equivalent combination of education and experience.
• Strong attention to detail.
• Ability to work in a face paced, team-oriented environment.
• Ability to act with a sense of urgency, while maintaining accuracy and data integrity.

**For immediate consideration please send an updated copy of your resume to Megan at mmantlo@apexsystems.com and use the link below to put a call on my calendar**

https://apexsystems.sensehq.com/scheduler/9018685979178889313/15-minute-meeting

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.

Employee Type:
FullTime

Location:
Rancho Cordova, CA, US

Job Type:
Scientific and Clinical

Date Posted:
October 13, 2022