Job# : 2034551

Job Description :

Apex is partnering with our pharmaceutical client to hire an Associate Quality Partner in Pleasanton, CA!

To directly apply, please email your resume to Shelby at email protected .

Associate Quality Partner

Location : Pleasanton, CA (Onsite)

Pay Range : $35 - $40 / hour with flexibility DOE

Duration : 1 year contract

As an Operations Quality Associate Quality Partner, your primary responsibilities will be supporting document control, equipment management activities and visual inspection of finished good products.

You are accountable for ensuring your contributions are delivered in a way that lives up to our commitments to each other and the ClientCommitments.

You work as a strategic business partner to help contribute more to the team, customers and patients and help mitigate significant compliance issues within your area of influence.

Your contributions help lead to developing and producing safe, quality products and services that meet customer requirements throughout the entire lifecycle.

You push the boundaries to enable and implement smart, risk-based compliant processes that result in quick and efficient innovation.

Responsibilities :

• Act as a Document Control coordinator (i.e. redlining documents, routing documents in electronic document management system, training users on document control process).
• Support equipment management activities (i.e. scheduling vendors for calibrations, PM, and repairs, inducting new equipment, updating equipment status, monitoring equipment alarms).
• Perform visual inspection of finished goods to ensure accuracy, completeness, appropriate release and control of products (review product information, generate Certificate of Analysis).
• Support non-conformance investigations and corrective actions.
• Compile and maintain Quality metrics to ensure compliance with quality system requirements and continuously promotes Right First Time.
• Participate and implement process improvements to meet business needs. Drive innovation within your area of influence.
• Responsible for performing activities as required to meet Operations Quality goals and objectives with direction as appropriate.
• Communicating significant quality or regulatory issues and risks that may impact product quality or regulatory compliance in a timely manner.
• Work day to day with limited supervision to correctly complete daily scheduled and unscheduled activities. Specific assigned tasks are completed independently.
• Other duties as assigned.

Relevant Skills :

• Proficient in Microsoft Word and Excel (redlining and formatting documents)
• Basic understanding of Quality Management Systems such as Good Manufacturing Practices (cGMP) Good Documentation Practices, Production Controls, Training, etc
• Familiarity with applicable local and international regulations
• Experience with SAP, ERP systems a plus

Education / Experience :

Associates, Bachelors or Masters Degree in Life Sciences or equivalent experience (preferably 3-5 years in biotech / pharmaceutical / medical device industry).

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 email protected or 844-463-6178 .

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning.

We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package.

Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico.

VEVRAA Federal ContractorWe request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.

We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic.

Last updated : 2024-06-28