QC Chemist

POSITION SUMMARY

The Quality Control Chemist-II is responsible for performing a variety of complex analytical testing, ensuring the quality of dietary supplements and OTC products through testing, documentation, and compliance with regulatory standards. This position also involves reviewing and maintaining SOPs, Testing Procedures, calibrations, and other controlled documents to support quality assurance activities. Additionally, the Chemist-II will assist with troubleshooting and minor repairs of laboratory equipment and support stability testing and documentation. This mid-level position will require more independent work, the ability to mentor QC chemist-I and Lab Tech personnel, and involvement in process improvements and corrective actions.

ESSENTIAL FUNCTIONS

(Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills and other characteristics. This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)

1. Coordinates with other QC Supervisors and laboratory management so that the shared resources such as laboratory instruments, reagents, etc. are available for assigned staff to perform their job duties effectively and efficiently.
2. Performs the pharmaceutical OTC & Dietary supplement analysis to support OTC & Dietary Supplement manufacturing which includes assay, impurity, dissolution testing, content uniformity, and physical testing.

1. Conduct Analysis in compliance with cGMP requirements, compendia standards, and internal procedures.
2. Maintain accurate record of analysis and perform documentation to company standards
3. Perform laboratory analysis right first time, contemporaneous documentation, analyze and document the results.
4. Notify manager immediately of nonconforming data or unexpected occurrences.

1. Reviews and analyzes the stability samples and associated analytical data, prepares or assists in preparing Stability Summary Reports for Annual Product Review Reports.
2. Reviews/Checks of analytical data by following test methods/SOPs.
3. Performs operational qualification on analytical instruments, analytical method verification/validations, validation protocols and reports for analytical methods. 

1. Conducts laboratory investigation (OOS/OOT) under the supervision of laboratory management.
2. Organize work schedule to complete assigned tasks efficiently and on schedule.
3. Work under direction provided by supervisor and other duties as assigned

1. Assist in Training and monitoring of the new hires (trainees) in learning or performing basic skills and assists in evaluating the need of any potential equipment for laboratory.
2. Ensures the laboratory is kept in a safe working environment and in compliance with OSHA and other laboratory safety standards.
3. Maintains knowledge of the latest guidelines of regulatory requirements of International Conference of Harmonization, USP, USFDA and OSHA. Complies with all regulatory/ in-house requirements may include but not be limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation.
4. Assists in compilation of regulatory documents.
5. Managing the Pharmacopeia changes and up gradation and implementing the same after upgrading the change repeated documents through proper channels of change control and training to all concerned.

EXPERIENCE AND QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the experience and education required:

     EDUCATION & EXPERIENCE

o Bachelors degree in Chemistry or related science field with eight (8) to ten (10) years lab experience in a pharmaceutical chemical or related industrial experience; preferably solid dosage forms manufacturing. Method Development experience is preferred.

o   Masters degree or higher with six (6) to eight (8) years of progressive lab experience in a pharmaceutical chemical or related industry; preferably generic pharmaceuticals. Method Development experience is preferred.

o Demonstrated skills and experience in leading a group of QC Chemists.

     COMPUTER SKILLS

o Basic knowledge of computers using MS Office, MS Outlook and business software systems commonly used in the pharmaceutical industry required.

     MATHEMATICAL SKILLS

o Requires a strong knowledge of algebra, calculus and statistics and how they are applied.

o Math skills commensurate with scientific background are required.

KNOWLEDGE, SKILLS AND ABILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills and abilities required:

  INDUSTRY KNOWLEDGE: Knowledge and experience of applicable FDA regulatory standards and requirements for the solid oral dosage manufacturing required.  Knowledge of analysis of pharmaceutical dosage forms and raw materials utilizing HPLC, GC, ICP-MS, UV, TLC, dissolution testing, spectroscopic and wet chemistry techniques is a plus.

  COMMUNICATION SKILLS: Advance level of written and verbal communication skills with the ability to read, technical procedures or governmental regulations. Ability to write reports, and required documentations.

  REASONING ABILITY: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Must possess initiative and trouble shooting ability.