Associate Quality Analyst II

Pinnaql, Inc.; Barceloneta (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Pinnaql, Inc. seeks an Associate Quality Analyst II to resolve supplier quality issues, manage change notifications, and maintain supplier status within a regulated lifecycle. The role emphasizes investigations, CAPAs, and collaboration with QA teams.

Ideal candidates bring 2+ years in pharma/biotech/medical device settings, strong cGxP knowledge, and proficiency in MS Office. Extended hours, possibly weekends and holidays, may be required.

Qualifications

• Bachelor's degree in natural sciences, biology, chemistry or engineering.
• Minimum of 2 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process/manufacturing areas.
• Fully bilingual (English/Spanish) with excellent oral skills.
• Proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance and how they apply to compliance.
• Good verbal and written communication.
• Good problem solving and analytical skills.
• Good interpersonal/communication skills.
• Good negotiation skills.
• Good analytical skills.
• Technical writing skills and investigations processes.
• Available to work extended hours, weekends and holidays.

Responsibilities

• Coordinates resolution of quality and performance issues with suppliers and Manufacturing Quality Assurance.
• Monitors and manages implementation of new and existing processes affecting vendor product quality.
• Establishes contact with suppliers regarding quality issues (nonconformity, deviation, defect report, waivers, etc.).
• Assesses supplier change notification (SCN) and ensures timely completion.
• Evaluates Specification Acceptance Letter exceptions and escalates as needed.
• Updates SAP with current specification data, supplier site approvals, and purchasing controls.
• Maintains cooperative relationships with plant and company departments to ensure material integrity.
• Serves as liaison with other Quality areas, Plant departments, and TPMs as needed.
• Supports follow-up and closure of management reviews actions.

Skills

Bilingual English/Spanish

cGxP knowledge

Verbal and written communication

Problem solving

Analytical skills

Technical writing

Investigations processes

Interpersonal relations

Negotiation skills

Education

Bachelor's Degree in Natural Sciences, Biology, Chemistry or Engineering

Tools

MS Windows

Microsoft Office

Job description

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Job Title

• Associate Quality Analyst II

Description

The Quality Analyst is responsible for resolution of issues with suppliers (investigations and corrective actions), maintenance of supplier status, evaluation and closure of supplier change notifications, supplier scorecards and SQA reports.

Responsibilities

• Coordinates resolution of problem relating to quality and performance of purchased materials with suppliers and Manufacturing Quality Assurance.


• The incumbent monitors and manages implementation of new and existing processes that ultimately impact vendor product quality assurance.


• Establish and document contact with suppliers concerning quality issues/concerns (i.e. nonconformity, deviation, defect report, waivers, etc.).


• Perform assessment of supplier change notification (SCN) of incoming material. Monitor supplier change notification review through Plant and company (as applicable) to ensure a timely completion.


• Evaluates Specification Acceptance Letter exception and assess need for elevation to area management, as needed.


• Updates and maintains the System Application Product (SAP) system with current specification date, approval of supplier sites and/or purchasing control.


• Interfaces with and maintains cooperative relationships with plant and company departments to assure the total integrity and usability of incoming materials.


• Serves as an effective liaison and maintains a cooperative relationship with other Quality areas, Plant departments, North Chicago, Bioresearch Center counterparts, and TPMs as needed.


• Assists section with the follow-up and close out of the management reviews action items upon their implementation.


• Ensures that all quality goals are met, and all practices and procedures comply with policies and applicable regulations for the Quality areas under his/her responsibility.


• The Quality Analyst is responsible for resolution of issues with suppliers (investigations and corrective actions), maintenance of supplier status, evaluation and closure of supplier change notifications, supplier scorecards and SQA reports.

Qualifications

• Bachelor's Degree in Natural Sciences, Biology, Chemistry or Engineering.


• Minimum of 2 years of experience in direct pharmaceutical, medical device or biotechnology industries.


• Experience in direct process / manufacturing areas.


• Must be fully bilingual (English / Spanish) with excellent oral skills.


• Must be proficient using MS Windows and Microsoft Office applications.


• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.


• Good verbal and written communication


• Good problem solving and analytical skills


• Good interpersonal relations/communications skills


• Good negotiation skills


• Good analytical skills


• Technical Writing skills and investigations processes.


• Available to work extended hours, possibility of weekends and holidays.

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.