Quality Analyst II

Who we are

The opportunity

POSITION SUMMARY
    
This role provides Quality Assurance support to Manufacturing, Supply Chain, and Quality Control Laboratories. Responsibilities include reviewing and approving QA methods, procedures, protocols, investigation documents, and change control documents. The position uses trend and investigational data to improve processes and reduce failures, while representing the quality department on cross-functional teams.

ESSENTIAL AREAS OF RESPONSIBILITY 

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 providing a thorough and timely review and approval of cGMP documents and processes such as those related to deviations, investigations, equipment and facilities Maintenance and calibration, protocols and reports, and facility controls, instruments and procedures.
•    Responsible for working with operating departments to facilitate process improvements and lean concepts. 
•    Responsible for participating in cross functional improvement and process monitoring teams to mitigate unfavorable trends.
•    Responsible for providing first response and ongoing QA presence for quality and compliance issues on the manufacturing floor and as needed in the laboratories.
•    Responsible for evaluating reports of deviations from defined processes and working with QA to determine if incidents should be escalated to an event investigation.
•    Responsible for conducting comprehensive investigations of complex and/or challenging events as assigned.
•    Responsible for completing all actions necessary in system to document investigations, identify root causes, create and assign appropriate CAPA’s and gain approval and closure of an event.
•    Responsible for investigating critical events, supporting other quality team members in the analysis and documentation.
•    Responsible for compiling and maintaining metrics and tracking logs for site’s quality KPI’s or other functions.
•    Responsible for supporting activities within electronic systems as needed, such as LIMS, TrackWise, EAM 
•    Responsible for serving as QA backup as final review/release of production batch records.
•    Responsible for completing training requirements and maintaining compliance with all assignments.   
•    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.

Your experience and qualifications

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 or equivalent with a minimum of three years relevant progressive QA experience in the pharmaceutical or a related industry.
•    Prefer degree in Science or Engineering.
•    Requires experience with and an in-depth knowledge of cGMP and other applicable industry regulatory requirements as they relate to the production of pharmaceutical products and associated quality systems.
•    Requires experience with the handling of deviations, investigations and CAPA’s.
•    Experience with Manufacturing/Quality systems such as Trackwise, Labware, Veeva, Learning Management Systems and statistical software preferred.
•    Experience with laboratory related investigations/inquiries preferred.
•    ASQ/CQE/CQA Certification preferred.
 
Skills/Knowledge/Abilities:
•    Detail oriented with ability to analyze information and create corresponding performance metrics.
•    Computer proficiency with comprehensive working knowledge of MS Office products and computer relational databases.
•    Ability to demonstrate sound judgment and decision making.
•    Ability to build and maintain collaborative relationships between teams, departments and business units.
•    Communicate effectively with excellent written and oral communication skills.
•    Interact positively and collaborate with co-workers, management and external partners.
•    Manage conflict and negotiate resolution.
•    Self-directed with ability to organize and prioritize work. 
 

Problem Solving:
•    Proactively works on problems of a moderate to complex scope where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.
•    Seeks out all resources when selecting methods and techniques for obtaining results.
•    Acts independently and proactively to recommend and administer methods and procedures for problem resolution.

TRAVEL REQUIREMENTS
•    N/A

PHYSICAL REQUIREMENTS:
Frequent:
•    Using fingers to perform activities such as picking, pinching or typing.
•    Repetitive Motions – frequent motions of the wrists, hands and/or fingers.
•    Sitting for extended periods of time.

Occasional:
•    Standing for extended periods of time at work station or equipment.
•    Walking to move short distances quickly and frequently.
•    Grasping – applying pressure to an object with the fingers and palm
•    Lifting – raising objects from lower to upper and/or moving objects horizontally – up to 25 lbs.

Visual Acuity:
•    Perform activities such as computer work, preparing and analyzing data, extensive reading, visual inspection involving small defects, small parts and/or operation of machines (including inspection), using measurement devices and/or assembly or fabrication of parts at a distance close to the eyes.

WORKING ENVIRONMENT:
•    Occasional exposure to moderate to loud noise levels.
•    Occasional exposure to moving mechanical parts or equipment.
•    Occasional exposure to fumes, odors, dusts, mists, gasses or vibrations.
•    May be required to wear personal protective equipment (PPE) as needed when in production areas (i.e. safety glasses, respirator, hearing protection, gloves, etc.).

Enjoy a more rewarding choice

We offer a competitive benefits package, including:
•    Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
•    Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
•    Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
•    Life and Disability Protection: Company paid Life and Disability insurance.
•    Additional benefits include, but are not limited to, 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 and Long Term Disability and more. 

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.   

Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.  
 

Important notice to Employment Agencies - Please Read Carefully  
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities.  All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.