Position Title: Quality Assurance Specialist - Supplier Quality Agreements
Work Location: Irvine, CA 92612
Assignment Duration: 6 months (Possible extension)
Work Arrangement: On-site (remote time will be determined)

Key Qualifications & Preferred Experience:

Bachelor's degree (4-year college) in a pharmaceutical or related scientific field would be ideal.
Minimum 5 years of relevant experience preferred; flexibility depending on fit, but not open to entry-level candidates.
Experience in supplier quality agreements strongly preferred, but candidates with robust experience in quality systems and documentation management who understand supplier control processes will be considered.
Experience in supplier quality management and generating quality agreements.
Knowledge of Quality Systems, cGMPs, ICH, EU, FDA, and MHRA regulations and requirements.
Proficient in Microsoft Word and document management systems (word processing is a key part of the job).
Good interpersonal and communication skills with internal and external customers, both oral and written.
Strong attention to detail and good command of business English, spelling, grammar, and punctuation.

Position Summary:

The position primarily focuses on writing, updating, and maintaining quality agreements with global suppliers.
Requires daily communication with both internal sites and external suppliers worldwide through emails, document reviews, and virtual meetings to align on quality agreement content and ensure comments are properly addressed.
Tasks include drafting new agreements, updating existing ones, uploading agreements into the documentation system, generating metrics, and following up with stakeholders.
Frequent interaction with global sites and suppliers to coordinate feedback, review comments, and resolve all inputs before finalization.
Manage templates, update SOPs or work instructions, and maintain documentation consistency across supplier agreements.
Ensure compliance with GxP, SOPs, and internal policies.
Requires independence, attention to detail, and the ability to manage 25-30 quality agreements simultaneously.
Strong background in supplier quality management, quality systems, and regulated documentation control is key.
Work is documentation-heavy, requiring excellent written and verbal communication, advanced Word processing skills, and strong organizational ability.
The environment is fast-paced, requiring self-motivation, focus, and minimal supervision.

Key Responsibilities:

Prepare new quality agreements with various suppliers.
Update and maintain existing quality agreements.
Upload global quality agreements into the document repository.
Generate metrics related to quality agreements.
Carry out responsibilities in accordance with organizational policies, procedures, and applicable laws.
Comply with all GxP, safety requirements, SOPs, and company policies.

Supplier Quality Assurance Specialist at Spectraforce Technologies

Job Description

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