Quality Assurance (QA) Specialist III

Pinnaql, Inc.; Barceloneta (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

Pinnaql is seeking a Senior Product Quality Assurance (PQA) Analyst to support TPM plants, approve manufacturing directions, review investigations, and drive CAPAs while ensuring cGMP compliance and regulatory readiness. You will coordinate across Quality, Regulatory, Technical and Supply Chain teams, perform annual Product Quality Reviews, and act as TPM liaison for regulatory submissions.

Candidates need 6+ years in pharma/biotech, a Bachelor's in Engineering or Science, bilingual

Qualifications

• Bachelor's Degree in Engineering or Science.
• Minimum of 6 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.
• Change plan, Exception Reports, SAP and LRMS experience is highly preferred.
• Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences.
• Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization.
• Assures the quality of manufactured products and processes per SOPs and GMP.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.

Responsibilities

• Maintains an effective liaison and cooperative relationship with other Areas including but not limited Quality, Regulatory, Technical, Supply Chain, along with the TPM sites.
• Ensures that bulk drug substance and/or drug product production at TPM sites is performed as per current good manufacturing practices, according to local procedures and as per specifications and manufacturing directions provided by QA Operations.
• Ensures TPM procedures including but not limited to raw material specification, product specification, test methods, supplier change notification, shipping, are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreement with TPM site.
• Review and approve manufacturing directions to the production floor.
• Provide support to PQA in global projects and events to ensure intended results are achieved; including planning, risk analysis, and implementation.
• Ensures investigations of TPM plant events related but not limited to process, laboratory, raw materials are completed thoroughly and documented accurately, including adequate product impact analyses and corrective and preventive action for plant events are documented.
• Perform annual Product Quality Review according to global procedure to comply with regulatory requirements.
• Participates in Trend Review Board to monitor process track and trending.
• Participates in the Global Change Review Board (GCRB) meeting as TPM representative to evaluate global changes related but not limited to supplier change notifications, process, laboratory, and regulatory submissions that impacts all sites.
• Generates detailed change management plans related to TPM plants changes to ensure intended results are achieved; including planning, risk analysis, and implementation.

Skills

Quality Assurance

GxP Compliance

Regulatory Liaison

Technical Writing

Cross-functional Collaboration

Education

Bachelor's Degree in Engineering or Science

Tools

SAP

LRMS

MS 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:

• Quality Assurance (QA) Specialist III

Description

The Senior Product Quality Assurance (PQA) Analyst has various objective/functions related to Third Party Manufacturing (TPM) plants and PQA functions. During routine operations, the Senior PQA Analyst is responsible for supporting the day to day Quality Assurance activities related to the TPM plants including but not limited to approval of manufacturing direction to the production floor, review and approval of manufacturing, laboratory, and raw material investigations, assess product impact analysis and corrective and preventive action for events, review and approval of changes as applicable. The Senior PQA Analyst also is responsible to evaluate supplier change notification, monitor process track and trending, and perform annual Product Quality Reviews. This person also acts as a liaison between company regulatory areas and TPM plants for regulatory submission.

Responsibilities

• Maintains an effective liaison and cooperative relationship with other Areas including but not limited Quality, Regulatory, Technical, Supply Chain, along with the TPM sites.
• Ensures that bulk drug substance and/or drug product production at TPM sites is performed as per current good manufacturing practices, according to local procedures and as per specifications and manufacturing directions provided by QA Operations.
• Ensures TPM procedures including but not limited to raw material specification, product specification, test methods, supplier change notification, shipping, are in compliance with cGMP, policies, regulatory approvals, and Quality Technical Agreement with TPM site.
• Review and approve manufacturing directions to the production floor.
• Provide support to PQA in global projects and events to ensure intended results are achieved; including planning, risk analysis, and implementation.
• Ensures investigations of TPM plant events related but not limited to process, laboratory, raw materials are completed thoroughly and documented accurately, including adequate product impact analyses and corrective and preventive action for plant events are documented.
• Perform annual Product Quality Review according to global procedure to comply with regulatory requirements.
• Participates in Trend Review Board to monitor process track and trending.
• Participates in the Global Change Review Board (GCRB) meeting as TPM representative to evaluate global changes related but not limited to supplier change notifications, process, laboratory, and regulatory submissions that impacts all sites.
• Generates detailed change management plans related to TPM plants changes to ensure intended results are achieved; including planning, risk analysis, and implementation.

Qualifications

• Bachelor's Degree in Engineering or Science.
• Minimum of 6 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.
• Change plan, Exception Reports, SAP and LRMS experience is highly preferred.
• Proven ability to adapt communication style for a variety of modes as well as for multicultural audiences.
• Strong interpersonal relations / communications skills. Ability to effectively communicate across all levels of the organization.
• Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).
• 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.