Standard Homeopathic Company a well-established pharmaceutical manufacturing company has an exciting opportunity for a HPLC Analyst. Our company is over 100 years old and robustly growing.

Summary: The HPLC Analyst will be involved in supporting multiple on-going projects. Activities include performing primarily HPLC analysis in a GMP/GLP environment for the purposes of release testing, and analysis required to support manufacturing functions (engineering, validation, demonstration batches, etc.), as well as on-going stability studies. The HPLC Analyst will work with their manager and a Senior Scientist to coordinate work with cross-functional team members, peers, and the Validation groups.

Essential Duties and Responsibilities
Perform testing using analytical equipment (HPLC, IR, TOC etc.).
Serve as in-house Subject Matter Expert on HPLC instrument operation.
Participate in Tech Transfer and method development activities with R&D personnel.
Perform analytical method transfer, and validation as directed from provided protocols as a major part of this role.
Process and interpret chromatographic data independently & communicate significance of results to management, while maintaining Data Integrity standards.
Enter experimental information into lab notebooks and process analytical data accordingly.
Coordinate with team members to ensure seamless analytical coverage during manufacturing campaigns and on-going stability studies. Also support new project activities, as needed.
Coordinate with team members to verify each other’s data by reviewing in a timely manner.
Take personal responsibility to meet analytical testing and data verification deadlines.
Review analytical data for accuracy and release/reject results.
Review and edit of protocols, reports, or other technical documents, and present project data to group, as needed.
Maintain documentation, equipment and work area in orderly condition at all times.?May be required to perform other duties as assigned or as needed.

Supervisory Responsibilities: This position has no supervisory responsibilities.


Education and/or Experience
Must have a Bachelor’s degree in Chemistry or related science with 5 + years’ experience in a regulated industry (i.e. pharmaceutical, dietary supplement, biotech, etc); or equivalent combination of education, training and/or experience.
Experience with USP is required.
Experience with analytical method verification, development, validation or transfer, is required.
Experience in operating, maintaining, and troubleshooting HPLC systems is required.
Experience using analytical instrumentation including analytical balances, OTC, spectrophotometers, etc. is required.
Experience working in a regulated (i.e. FDA, NPA, etc) GMP environment is required.
Experience in maintaining data integrity is required.
Hands-on experience with chromatography and equipment is required.
Experience with EP, BP, ACS, and ICH guidelines is preferred.
Experience reviewing audit trails a strong plus.
Experience with Waters HPLC equipment is preferred.
Experience with preventive maintenance and calibration of instruments is preferred.

Knowledge, Skills and Abilities
Good understanding and in-depth knowledge of cGMP, SOP's, GLP, QA/QC.
Good communication skills both oral and written.
High energy, self-motivated individual who is detail focused, organized, and able to multi-task between multiple active projects.
Ability to work under pressure and perform tasks on schedule with minimal supervision.
Able and willing to work in a team environment and participate in cross functional team activities.
Ability to work with others and independently.
Ability to write routine reports and correspondence.
Able and willing to work in a team environment and participate in team activities.
Ability to train others.
Competency to properly gown for and function within a GMP environment.
Discipline to consistently follow SOPs, GMPs, and safety precautions.
Strong analytical reasoning skills & excellent written and verbal communication skills.
Knowledgeable in Microsoft Office, Outlook, and similar programs.