Quality Control Analyst

Teva Job Opportunity

We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we're dedicated to addressing patients' needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

This position is responsible for performing testing and analysis of incoming materials, intermediates, finished products, swab samples, and other samples to support the commercial and development activities at the site in compliance with all regulatory requirements, company policies and procedures.

All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments.

• Responsible for testing and analyzing incoming materials such as intermediates, finished products and swab samples.
• Responsible for preparing, maintaining and reviewing thorough records, documentation on solutions, sample preparation and investigational/experimental samples.
• Responsible for supporting laboratory investigations into Out of Specification/Out of Trend results or other laboratory events.
• Responsible for performing revisions to documentation such as Standard Operating Procedures, Test Methods and Specifications.
• Responsible for coordinating and sending materials for contract laboratory testing.
• Responsible for compliance with DEA and site requirements regarding the handling, use and disposal of controlled substances.
• Responsible for performing verification of compendial methods.
• Responsible for providing training to other analysts on activities for which they have developed a level of expertise.
• Responsible for performing peer review on documents which may also become a full-time role.
• Responsible for assisting with activities associated with the stability program including sampling and statistical analyses.
• Responsible for assisting with activities related to the sampling of incoming materials as needed.
• Responsible for maintaining work areas and performing job functions in a safe and efficient manner in accordance with company policies and procedures, Good Manufacturing Practices (cGMP's), Standard Operating Procedures (SOP's) and Batch Record instructions.
• Responsible for performing additional related duties as assigned.

Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.

Education/Certification/

Experience:

• Requires a Bachelor's degree, preferably in Chemistry or Microbiology, or equivalent education/experience with a minimum of 3 years relevant progressive experience in a Quality Control Laboratory environment.
• Solid understanding of the principles of analytical chemistry as it applies to HPLC, GC, FTIR, UV-Vis and other general analytical techniques.
• Requires working knowledge of cGMP, DEA and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
• Prefer experience with Laboratory Information Management Systems (Labware LIMS and/or Empower preferred).

Skills/Knowledge/Abilities:

• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as LIMS, Trackwise and Qdocs.
• Ability to effectively document a process, explaining scientific and/or technical ideas in writing (technical writing skills).
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers, management and other internal stakeholders.
• Self-directed with ability to organize and prioritize work.
• Detail oriented with ability to identify errors and/or inconsistencies while performing tasks.

Problem Solving:

• Works on problems of moderate scope where evaluation of contributing factors requires analysis of situation or data.
• Exercises judgment within broadly defined practices and policies and selects methods and techniques for obtaining solutions.
• Selects methods, techniques, and evaluation criteria for obtaining results.
• Acts independently and proactively to recommend methods and procedures for problem resolution.

WORKING ENVIRONMENT

• Exposure to fumes, odors, dusts, mists or gasses (for non-office).
• Exposure to moving mechanical parts or moving equipment.
• Exposure to low to moderate to loud noise levels.
• May be required to wear personal protective equipment (PPE) as needed for assigned area and/or process (i.e. safety glasses,…