Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, No eye contacts allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information:

Manati, Puerto Rico / PSG - Oral Solid Dose

Compensation: $11.23/hr + competitive benefits and annual merit increase eligibility

Shift Information: Monday-Friday 10am-7pm (overtime as needed)

How Will You Make an Impact?:

The Quality Assurance Technician primarily works with other members of the Quality & Technical Services group to assist in the timely review of implemented manufacturing, quality control and/or facility records to meet required timelines for batch release.

A Day in the Life:Participates in review of GMP processes, documents and records pertaining to Quality Control, including methods and results, specifications, stability, Assay Qualification and Validations, microbiology and Environmental Monitoring including trending data.Supports QA review of GMP Facilities documentation including equipment, automation, computerized systems and utilities qualification and validations protocols and reports; and, calibration, preventative maintenance and monitoring records including client audits and regulatory inspections.Assists in QA robust document review and approval activities to meet specified timelines and ensure the adherence to Quality Agreements, regulatory requirements and site procedures. Tracks review and cycle times of relevant records. Documentation may include test records, protocols, reports, batch records, SOPs, and technical documents in accordance with site procedures.Helps to create procedures or processes to fulfill quality related improvements.Supports QA in the areas of batch record review and Product release as needed and directed by supervisor.Performs inspection and release activities associated with rooms, raw materials, and client imprinted materials.Education:

High school diploma or equivalent required.

Experience:Required: No previous work experience requiredPreferred: Experience in Quality Assurance or Quality ControlPreferred: Experience in a cGMP environmentKnowledge, Skills, Abilities:Ability to speak, read, write and interpret documents such as standard operating procedures and audit reports.Communicate effectively to key collaborators of QA batch release group and members of other departments.Basic arithmetic, algebra and geometry.Physical Requirements / Work EnvironmentWhat We Offer

Compensation

Competitive Hourly Pay Rate at $11.23/hrAdditional shift differential for 2nd shift and 3rd shift positionsAnnual performance-based bonusAnnual merit performance-based increaseChristmas Bonus

Excellent Benefits

Benefits & Total Rewards | Thermo Fisher Scientific Medical, Dental, & Vision benefits-effective Day 1Paid Time Off & Designated Paid HolidaysRetirement Savings PlanTuition ReimbursementEmployee Referral BonusCareer Advancement Opportunities