Quality Technician (3Rd Shift) (Visual Test/Compression/Manufacturing) (Pharma/Medical Device)

• 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 compression, coating, and printing/sorting areas of tablets.
• Responsible for reviewing documentation of "in-process" compression test balance.
• Perform "line clearance" verification of final packaging lines.
• Handle archive and return samples sent by customers of products manufactured at APL. Handling includes: Receiving samples, assigning locations, and storage according to their storage conditions.
• Establish written communication through the electronic correspondence system (e-mail) as part of work tools to receive requests from APL and Chicago staff to provide them with the information they require.
• Work with the preparation of samples with ultra-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 balancing of controlled products.
• Destroy samples according to the retention time schedule established for the procedures using safety requirements for potentially harmful biological material waste.
• Document inspections by describing what was observed in a written report in accordance with the Quality System Regulation.
• Handle and document temperature records of rooms and storage equipment for archive and return samples.
• Perform applicable process tests (Visual, hardness, thickness, weight, disintegration, and viscosity).
• Responsible for executing tasks assigned according to operational area needs.
• Provide assistance to operations in accordance with environmental management systems, Operational Health and Safety (EH&S in English), and promote continuous improvement.

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

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

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

• Fully Bilingual Spanish & English with written communication skills.
• Knowledge of good manufacturing (GMP) and safety practices.
• Basic knowledge in computer systems.
• Available to learn and work.

• POMS SAP Sample Management.

• Team work.
• Mostly in areas of manufacturing and packaging and sampling

• Associate (Preferred)

• CGMP: 1 year (Preferred)
• SAP: 1 year (Preferred)
• performing visual tests in Mfg. environment: 1 year (Preferred)
• Pharma or medical device or biotech industry: 1 year (Preferred)
• review document of in-process compression test balance: 1 year (Preferred)
• Perform line clearance verification of final packaging lines: 1 year (Preferred)

• Barceloneta, PR 00617 (Preferred)

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