JOB PURPOSE

Plans, organizes, schedules and directs the chemistry laboratory operations to assure that the analytical support is provided to all the products and materials at their different stages in compliance with good laboratory practices delineated in GMPs, company standards and regulatory requirements (FDA Guidelines for laboratory operations), corporate/ local policies and procedures, as well as requirements from regulatory bodies of countries where product is marketed. Provides technical support and coordinates projects, any required research and other laboratory tasks to chemical laboratory. Performs audits and modify SOP's and protocols to assure company compliance with all internal and external standards.

Ensure all tasks associated to the laboratory operation are scheduled and executed according to company standards. Ensures that all change controls and validations applicable to processes and/or laboratory are completed on a timely basis. Ensures that LIMS and laboratory software’s are updated following any changes in version and/or specifications. Safety and product Quality must be a priority.

Participates in the decision-making process concerning regulatory/quality standards compliance in the above operations.

ESSENTIAL DUTIES AND RESPONSIBILITIES

1. Ensures that chemistry laboratory operations are performed according to good laboratory practices delineated in GMPs, company standards and regulatory requirements (FDA Guidelines for laboratory operations), and regulations applicable to countries where product is marketed.

2. Evaluates tests results to ensure compliance with specifications, policies, procedures and regulatory requirements. Evaluates trends and provides support and approves corrective and preventive actions to prevent recurrence. Leads and performs investigation of any out of specification results and system suitability are performed in a timely manner. Completes risk assessment when applicable.

3. Ensures and maintains product quality through compliance with QMS, meeting customers and corporate requirements.

4. Ensures follow-up to internal supplier failure to assure compliance to GMPs and internal policies. Evaluates possible risk factors involved in the sampling and analysis of product and materials.

5. Ensures that all analyst assigned to performed testing have been adequately trained in the tests and test methodology according to good laboratory practices delineated in GMPs, company standards and regulatory requirements (FDA Guidelines for laboratory operations).

6. Ensures timely completion of testing to support product releases, by an effective coordination of testing activities. Exercises effective status communication to other functional groups that depend directly of laboratory results. Ensures the use of EMS tools to visualize improvement opportunities and provide support to cost reduction and continuous improvement projects.

7. Ensures that laboratory documentation complies with good laboratory practices delineated in GMPs, company standards and regulatory requirements (FDA Guidelines for laboratory operations).

8. Responsible for maintaining all chemistry laboratory programs including, reference standards, training documentation, laboratory calibrations, procedures, monographs, specifications, laboratory housekeeping in compliance with the internal and external regulations, EHS, quality agreements and Stability programs.

9. Promotes team work and compliance with Baxter´s values and good business practices.

10. Prepares reports on a timely basis daily, monthly, quarterly or annually as required by the immediate supervisor, and areas it provides services to (monthly highlights, trends of the laboratory - quarterly and annually-, laboratory performance and trends of out of limit - monthly-).

11. Active participation in Company working teams and investigations.

12. Responsible for the appropriate dispose of laboratory chemical wastes (chemical reagents, discard chemical reagents) in the most safety and adequate way assuring Company compliance with all internal and external regulations.

13. Ensures reagent, supplies and equipment inventory is maintained.

14. Issue purchase orders as needed.

15. Ensures adequate availability of laboratory equipment and instrument systems. Ensures a PM and calibration program is in place and executed in compliance with good laboratory practices delineated in GMPs, company standards and regulatory requirements (FDA Guidelines for laboratory operations). Ensures coordination of repairs and maintenance of entire chemical laboratory.

16. Initiates and implement changes or new chemical procedures including data gathering. Capable to develop, modify and analyze protocols and procedures as required. Follow-up to processes/laboratory change control.

17. Responsible for the coordination, execution, reporting, validation, and transfer of analytical methods to ensure that the proper resources have been identified and are efficiently used.

18. Maintains a safe working environment and assures coherence to all company policies and practices.

19. Actively participate in Internal, External audit and inspections.

20. Accountable for the laboratory budget planning and adherence.

21. Support and lead areas as needed such as Validations.

22. Work execution onsite, and available to supports all working shifts.

SUPERVISORY RESPONSIBILITIES

Directly supervises Quality Technician, Chemist I, Chemist II and Sr. Chemist group. Carries out supervisory and technical guidance responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

EDUCATION and/or EXPERIENCE

Bachelors Degree or Master Degree in Chemistry. Chemical License (preferably). At least, five years of experience in supervisory role preferably in the pharmaceutical field with a solid background and experience in chemical laboratory, project management, validations and product transfer.

REQUIREMENTS

Knowledge of cGMP, DEA, and other applicable regulations

Good interpersonal and troubleshooting skills

Critical Thinking and analytical skills

Fully bilingual, (English and Spanish)

Knowledge in Microsoft Office System (Work, Excel, Power Point, etc.)

Shift:

3 rd

Pay Details: $31.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

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The Company will consider qualified applicants with arrest and conviction records subject to federal contractor requirements and/or security clearance requirements.