Specialist QA 35471

Inteldot; Juncos (PR); On-site; USD 60,000 - 80,000; Full time

Job summary

Inteldot is seeking a Quality Assurance specialist in Juncos, Puerto Rico, to support QA programs and oversee manufacturing operations. The candidate will manage processes, interact with regulatory agencies, and participate in cross-functional teams.

The role requires a Doctorate or Master's degree with 2 years of experience, or a Bachelor's degree with 4 years of experience in a related field. Strong communication and organizational skills are necessary for success.

Responsibilities

• Support Quality Assurance program in manufacturing and regulatory compliance.
• Perform batch record review and reconciliation.
• Initiate and lead cross-functional teams.
• Evaluate compliance issues.

Skills

Batch record review

Manufacturing operations oversight

Organizational skills

Cross-functional team leadership

Regulatory agency interaction

Communication skills

Data trending and evaluation

Education

Doctorate or Master's + 2 years Scientific experience

Bachelor's + 4 years Scientific experience

Job description

Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Shift (12 hour shift 5pm-5:30 am: Night shift Rotating coverage (including weekends and holidays))

Job Description:

Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities.

Requirements & Qualifications:

• Experience performing batch record (EBR) review, approval, and reconciliation
• Oversight manufacturing operations
• Manage events and decision making
• Strong organizational skills, including ability to follow assignments through to completion.
• Initiate and lead cross functional teams.
• Enhanced skills in leading, influencing and negotiating.
• Strong knowledge in area of expertise.
• Collaborate and coordinate with higher level outside resources.
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
• Demonstrate ability to interact with regulatory agencies.
• Strong word processing, presentation, database and spreadsheet application skills.
• Strong communication (both written and oral), facilitation and presentation skills.
• Strong skill in working independently and to effectively interact with various levels.
• Advanced data trending and evaluation.
• Ability to evaluate compliance issues

Education

• Doctorate OR Master’s + 2 years of Scientific experience OR Bachelors + 4 years of Scientific experience.