Pharmaceutical Scientist 2

2 months ago

Rockford, United States PCI Pharma Services Full time

Summary of Objective:

Primary function is to perform intermediate chemical and physical testing of pharmaceutical starting materials, components and finished products to client supplied and Pharmacopoeial methodology in accordance with regulatory standards with a high level of accuracy and minimal personal error. Testing is performed using techniques such as FTIR, UV, Karl Fisher, HPLC and Dissolution with calibration, maintenance and troubleshooting of this equipment. Training of analysts in techniques for which competency has been demonstrated. Authoring on-time investigations, participation in OOS investigations and assisting in the determination of root cause. There are no supervisory responsibilities.


Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.


GENERAL RESPONSIBILITIES


1.Receipt and logging of samples into LIMS including setting up new product/test and specifications

2. Works in an efficient manner to a high level of accuracy with minimal personal error

3. Generation and documentation of raw data in accordance with ALCOA principles

4. Knowledge of ICH Guidelines which pertain to job function

5. Knowledge of USP and EP general chapters which pertain to techniques within job function

6. Training of other analysts in techniques for which expertise has been demonstrated

7. Attendance at staff meeting/laboratory departmental communication huddles

8. On time completion of assigned training in ComplianceWire

9. Participate in internal Health and Safety audits including developing actions and follow up

10. Retains product on completion of testing and raw data upon issuance of analytical report/certificate of analysis

11. Maintains a high level of good housekeeping including ensuring that all glassware is disposed of and cleaned in a timely manner once analysis is complete and checked for compliance to specification 12. Maintains a high level of safety and highlights any potential unsafe act immediately to all and works with relevant personnel to prevent further occurrence

13. Ensure that all waste materials/solvents are disposed of in a safe and timely manner.

14. Implementation and execution of continuous improvement activities

15. Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory

16. Attendance to work is an essential function of this position

17. This position may require overtime and/or weekend work.

18. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

19. Performs other duties as assigned by Manager/Supervisor.


SPECIFIC RESPONSIBILITIES


1. Receipt and logging of samples into LIMS including setting up new product/test and specifications

2. Works in an efficient manner to a high level of accuracy with minimal personal error

3. Generation and documentation of raw data in accordance with ALCOA principles

4. Knowledge of ICH Guidelines which pertain to job function

5. Knowledge of USP and EP general chapters which pertain to techniques within job function

6. Training of other analysts in techniques for which expertise has been demonstrated

7. Attendance at staff meeting/laboratory departmental communication huddles

8. On time completion of assigned training in ComplianceWire

9. Participate in internal Health and Safety audits including developing actions and follow up

10. Retains product on completion of testing and raw data upon issuance of analytical report/certificate of analysis

11. Maintains a high level of good housekeeping including ensuring that all glassware is disposed of and cleaned in a timely manner once analysis is complete and checked for compliance to specification 12. Maintains a high level of safety and highlights any potential unsafe act immediately to all and works with relevant personnel to prevent further occurrence

13. Ensure that all waste materials/solvents are disposed of in a safe and timely manner.

14. Implementation and execution of continuous improvement activities

15. Play a role in creating and maintaining an atmosphere of teamwork throughout the laboratory

16. Attendance to work is an essential function of this position

17. This position may require overtime and/or weekend work.

18. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

19. Performs other duties as assigned by Manager/Supervisor.


Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

  • Bachelor's Degree in a related field and/or 1-5 years related experience and/or training.
  • College Level Mathematical Skills
  • Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
  • Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
  • Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

Preferred:

  • Ability to demonstrate attention to detail.
  • Ability to adapt to a changing work environment.
  • Ability to hold oneself in a professional manner.
  • Ability to identify and resolve problems in a timely manner.
  • Ability to exhibit sound and accurate judgement
  • Ability to demonstrate excellent time management skills
  • Ability to take ownership of issues and works towards resolution


Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

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