QA Technician I

Title: QA Technician I
Location: Barceloneta PR
Duration: 12+ Months
Pay Range: $14/hr - $14.50/hr

3rd shift work - During training, the first 2-3 months will be on 1st shift, then 2nd shift, and after that will move to 3rd shift - candidate must be available for all shifts based on customer needs.

Special Responsibilities:
List the essential responsibilities for the position in order of importance and priority for the job. Describe the expected outcome for this position. Each should support the overall purpose of the position.

• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Responsible for performing visual tests with acceptance and rejection criteria by attributes in the areas of compression, coating, and printed/lot tablets.
• Responsible for reviewing documentation of in-process compression tests.
• Perform verification of line clearance for the final packaging lines.
• Handle archive and return samples sent by clients of products manufactured at APL. Handling includes: receipt of samples, assignment of locations, and storage according to their storage conditions.
• Establish written communication through the electronic correspondence system (email) as part of the tools of their work to receive requests from APL and Chicago personnel to provide them the information they require.
• Work on the preparation of samples with extra-fine material; this involves taking photos and making arrangements to send them to the MS&T department.
• Communicate with scientists and researchers to agree on the delivery of requested samples.
• Execute counting and reconciliation of controlled products.
• Destroy samples according to the retention schedule established for the procedures, using safety requirements for potentially harmful biological material waste.
• Document inspections describing what is observed in a written report according to the Quality System Regulation.
• Manage and document temperature records of rooms and storage equipment for archive and return samples.
• Perform process tests (visual, hardness, thickness, weight, disintegration, and viscosity) as applicable.
• Responsible for performing tasks assigned according to the needs of the operational area.
• Provide assistance to operations according to Environmental, Health, and Safety (EH&S) management systems and promote continuous improvement.

Education:
Mention the minimum education requirements, skills, and practical knowledge needed.

• Associate degree, preferably in Natural Sciences or Technical/Vocational Degree.

Experience:
Mention the minimum experience required. Please include titles.

• Excellent interpersonal skills.
• Verbal and written communication skills in English and Spanish.
• Basic knowledge of cGMP.
• Basic knowledge of mathematics.

Disclaimer:
The paragraphs of essential responsibilities describe the general nature and level of work to be performed by individuals assigned to the position. These do not exhaustively describe all responsibilities, tasks, or skills required for this position. The incumbent may perform other functions as assigned.

Top 3-5 skills, experience, or education required for this position:

Fully bilingual in Spanish & English with written communication skills

Knowledge of Good Manufacturing Practices (GMP) and safety practices

Basic knowledge in computer systems

Available to learn and work

Nice-to-have (but not required) skills, experience, education, or certification:

• POMS, SAP, Sample Management

Work environment:

• Teamwork
• Mostly in areas of manufacturing, packaging, and sampling