Laboratory Technologist II, Stability

Vega Baja, PR

Training

Job Description - Laboratory Technologist II, Stability TRN-003624880

Approved 2.0, CURRENT

This information is confidential to Viatris. Page 1 of 3

JOB DESCRIPTION

JOB TITLE: Laboratory Technologist II, Stability REPORTS TO: Team Leader, QC- Stability

POSITION PURPOSE Performs a variety of basic to complex analytical laboratory analyses of raw materials, active pharmaceutical ingredients, finished products and special projects samples following established procedures and techniques.

Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.

ESSENTIAL DUTIES AND RESPONSIBILITIES To perform this position successfully, an individual must satisfactorily perform each essential duty. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

1. Perform stability activities for new and existing products. 2. Performs analytical testing following established procedures in conformance with the official material

specifications, analytical procedures, and laboratory Standard Operating Procedures to meet quality and accuracy requirements.

3. Document the results in logbooks, laboratory notebooks, working papers or LIMS system according to established procedures.

4. Reports raw data and performs calculations and collects/prepares data for evaluation. 5. Interprets and evaluates the analyses in terms of accuracy and precision and conformance to

established criteria. Anticipates, identifies, and solves problems related to laboratory analysis. 6. Applies existing techniques and procedures and may recommend and implement modifications for

improved efficiency, or devise and develop new analytical methods and techniques. 7. Reviews and evaluates analytical reports of stability samples and or special projects that meet quality

standards and partner with other in re-testing and/or re-sampling. 8. Execute validation, compendial equivalencies, verifications and methods transfer protocols. Issuance

of investigations, deviations, and final reports. 9. Prepares and standardized solutions according to USP and/or official procedures. Records the

results in the logbooks, assay, and expiration date according to established procedures. 10. Prepares and checks all reagents and solutions in the laboratory for analytical processes to ensure

their compliance with compendial and standard procedures. 11. Assures that laboratory equipment is maintained in proper working conditions and verifies the

calibration date of laboratory instruments according to SOP’s and informs any malfunction to the laboratory Team Leader.

12. Utilizes computerized laboratory systems (LIMS, Empower, Trackwise and Documentum D2) to process analytical results, record the values on the reports provided, issuance of change Requests and Laboratory Investigations.

13. Follows procedures for the handling, movement, and disposal of samples. 14. Follows laboratory housekeeping procedures. 15. Maintains and uses all Reference Standard as required by applicable procedures. 16. Notifies to the Team Leader/Supervisor or designee of any Out of specification or Questionable

results and participates in the laboratory investigations. 17. Conducts safety talks or trainings and is acquainted with the Safety Data Sheet (SDS) which must

be read before using a reagent.

Printed by : Effective date :

Print date (EST):

The user is responsible for using the appropriate version of this document.

Yadira Garcia Freytes 14-Jul-2026 06-Jun-2025

Vega Baja, PR

Training

Job Description - Laboratory Technologist II, Stability TRN-003624880

Approved 2.0, CURRENT

This information is confidential to Viatris. Page 2 of 3

18. Responsible for seeking and actively participating in training in all applicable tasks related to the role, qualification programs and other site initiatives (Environmental, Safety and Professional development).

19. Ensures compliance with data integrity principles and documentation procedures. 20. Ensures Controlled Substance is managed as per Regulation requirements and following procedure

instructions. 21. Willing to work irregular hours, weekends, and holidays when necessary.

QUALIFICATIONS The qualifications listed below are representative of the minimum knowledge, skill, and/or ability required.

KNOWLEDGE Must possess knowledge of:

• Technical Skills of analytical laboratory equipment, testing and techniques

SKILLS AND ABILITIES • Computer literate • Ability to read and write in English and Spanish. Bilingual (English/Spanish) • Be able to communicate well and follow instructions • Team collaboration

SUPERVISION N/A

EDUCATION/EXPERIENCE

• BS in Chemistry, Biology, Biotechnology or in Natural Sciences fields and 3 to 5 years of experience in an analytical laboratory.

• Knowledge of NDA, ANDA, CMC and DEA/FDA regulations.

LICENSES/CERTIFICATIONS • Chemist License is preferable

LANGUAGE SKILLS Ability to read and interpret general business documents. Ability to write routine reports and general business correspondence. Ability to work with peers and communicate basic concepts.

MATHEMATICAL SKILLS Ability to solve equations, apply technical mathematical concepts, and perform complex computations.

REASONING ABILITY

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Print date (EST):

The user is responsible for using the appropriate version of this document.

Yadira Garcia Freytes 14-Jul-2026 06-Jun-2025

Vega Baja, PR

Training

Job Description - Laboratory Technologist II, Stability TRN-003624880

Approved 2.0, CURRENT

This information is confidential to Viatris. Page 3 of 3

Ability to solve problems with a variety of concrete variables through semi-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

Production Related May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms to lift and scoop. May be required to lift or maneuver boxes or containers using lifting equipment, as well as physically pushing, rolling or lifting. May be required to wear personal protective equipment including but not limited to: respiratory protection, safety glasses, hearing protection, safety shoes and protective clothing. Medium, lifting requirements.

WORK ENVIRONMENT The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties. (Fill in Work Environment: i.e. Normal office situation.)

DISCLAIMER: This description is based on management’s assessment of the requirements and functions of the job as of the date this description was prepared. It is a general guideline for managers and colleagues, but it does not purport to be an exhaustive list of all the elements of the job. Management reserves the right to modify the description at any time, or to vary the duties and responsibilities of the job on a temporary or indefinite basis to meet production, scheduling or staffing needs.

Printed by : Effective date :

Print date (EST):

The user is responsible for using the appropriate version of this document.

Yadira Garcia Freytes 14-Jul-2026 06-Jun-2025

Document Name : TRN-003624880

Title : Job Description - Laboratory Technologist II, Stability

Version : 2.0, CURRENT

Status : Approved

Electronic Signature

User Date (EST) Justification

Yadira Garcia Freytes 04-Jun-2025 14:40:55

Technical Approval

Wigberto Gonzalez Montoyo 06-Jun-2025 10:11:47

Manager Approval

Printed by : Effective date :

Print date (EST):

The user is responsible for using the appropriate version of this document.

Yadira Garcia Freytes 14-Jul-2026 06-Jun-2025