Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

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

• QA Specislist 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 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 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, 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 applicable policies and 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.
• Quality related work in the pharmaceutical or medical device Health Care Organization. Total combined minimum years of experience required - 2 years.
• Key Stakeholders: Suppliers, Purchasing, IQA, Materials Management, TPM's, Technical groups, Manufacturing, Quality Assurance, Compliance, Validation, etc.
  • Good problem solving and analytical skills
  • Good interpersonal relations/communications skills
  • Good verbal and written communication
  • Good negotiation skills
  • Quality related work in the pharmaceutical or medical device Health Care Organization. Total combined minimum years of experience required - 5 years.
• Technical Skills:
  • Good verbal and written communication.
  • Good problem solving and analytical skills.
  • Good interpersonal relations/communications skills.
  • Good negotiation skills.
  • Good analytical skills.
• Supplier Management Experience.
• Must be fully bilingual (English / Spanish).
• Must be proficient using MS Windows and Microsoft Office applications.
• Experience in pharmaceutical industry.
• Preference experience in incoming quality area.
• Available to work extended hours, possibility of weekends and holidays.

At Validation & Engineering Group, 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.

Validation & Engineering Group 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.