Note: The job is a remote job and is open to candidates in USA. Teva Pharmaceuticals is an innovative biopharmaceutical company with a world-class generics business focused on addressing patients’ needs worldwide. The Quality Control Analyst I performs testing and analysis of materials and products, supports laboratory investigations and stability activities, maintains documentation, and ensures compliance with regulatory and company requirements.
Responsibilities
- 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
Skills
- Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered
- 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
- 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
- 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, gloves, hearing protection, etc.)
- Prefer experience with Laboratory Information Management Systems (Labware LIMS and/or Empower preferred)
Benefits
- Generous annual leave
- Reward plans
- Flexible working schedules (dependent on role)
- Access to tailored health support
- Meaningful ways to give back to the community
- Learning programs
- Short-term projects
- Opportunities for internal growth
- Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
- 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
- Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
- Company paid Life and Disability insurance.
- Employee Assistance Program
- Employee Stock Purchase Plan
- Tuition Assistance
- Flexible Spending Accounts
- Health Savings Account
- Life Style Spending Account
- Volunteer Time Off
- Paid Parental Leave, if eligible
- Family Building Benefits
- Virtual Physical Therapy
- Accident, Critical Illness and Hospital Indemnity Insurances
- Identity Theft Protection
- Legal Plan
- Voluntary Life Insurance
- Long Term Disability insurance
Company Overview
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