Quality Analyst
Teva Pharmaceuticals
Date: 12 hours ago
City: Davie, Florida
Contract type: Full time
Who We Are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
Position Summary
This position is responsible for the evaluation of Investigations for Operations and Laboratories; CAPAs, Effectiveness Checks, Protocols and Reports from but not limited to: Analytical Method, Equipment Qualifications, Process Validations. Also, review and approve Change Control System, LIMS/MES/SAP changes, Electronic Document Management System for the procedures, forms and any documentation supporting the sites in strict accordance with all Standard Operating Procedures, Current Good Manufacturing Practices, Company policies and procedures, and Food and Drug Administration requirements governing the manufacture of pharmaceutical products. Responsible for identifying trends key areas an indicator from production and laboratories for implementation of corrective and preventive measures. This role requires close collaboration with cross-functional teams to ensure a seamless and successful achievement of Key Performance targets.
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.
Your experience and qualifications
PHYSICAL REQUIREMENTS:
We Offer a Competitive Benefits Package, Including
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 [email protected] 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.
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.
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
The opportunity
Position Summary
This position is responsible for the evaluation of Investigations for Operations and Laboratories; CAPAs, Effectiveness Checks, Protocols and Reports from but not limited to: Analytical Method, Equipment Qualifications, Process Validations. Also, review and approve Change Control System, LIMS/MES/SAP changes, Electronic Document Management System for the procedures, forms and any documentation supporting the sites in strict accordance with all Standard Operating Procedures, Current Good Manufacturing Practices, Company policies and procedures, and Food and Drug Administration requirements governing the manufacture of pharmaceutical products. Responsible for identifying trends key areas an indicator from production and laboratories for implementation of corrective and preventive measures. This role requires close collaboration with cross-functional teams to ensure a seamless and successful achievement of Key Performance targets.
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.
- Work closely with other Quality Engineer team members on activities for EDMS, Investigations, CAPAs, Effectiveness Checks, Protocols, Reports for Equipment Qualifications, Process and Method Validations and the Change Controls associated.
- Work closely with QC and Production for LIMS, MES, SAP changes.
- Work closely with Project Managers, R&D, Regulatory Affairs, Quality Control, Quality, Operations and Supply Chain teams for documents review and approval in a coordinated effort, and alignment on site priorities and launch objectives to ensure a seamless and successful KPIs.
- 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 completing all training requirements and maintaining 100% compliance with all assignments.
- Reviews and approves production and process control Standard Operating Procedures (SOPs) that are drafted, reviewed and approved by other organizational units.
- Support the identification, investigation, closeout of deviations and Corrective Actions & Preventive Actions.
- Coordinates with Operations to ensure compliance with and understanding of CGMPs, Company policies and practices, and safety procedures.
- Support inspections and audits to ensure compliance with CGMPs, SOPs, Company practices and procedures and governmental regulations.
- Prepare the monthly and quarterly Quality Council report for Deviations, CAPAs, CC, and any other Quality System required.
- Provides support, in the areas of problem resolution and TLMS projects.
- Ensures project deadlines and performance standards are established and met.
- Responsible for performing additional related duties as assigned.
- Responsible for completing all training requirements and maintaining 100% 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), and Standard Operating Procedures (SOP’s) instructions.
- Responsible for performing additional related duties as assigned.
Your experience and qualifications
- Requires Bachelor Degree preferably in Science, Engineering, Master Degree also preferrable from an accredited college or university, with a minimum of 5 years relevant progressive experience in the pharmaceutical industry.
- Preferably in a pharmaceutical manufacturing environment or related field.
- Strong Project Management and organizational skills.
- Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and or/techniques for resolutions.
- Responding to technical inquiries from management, peers, and regulatory agencies.
- Communicating clearly and concisely, both, orally and in writing.
- Operating scientific and personal computers.
- Managing multiple projects, duties, and assignments.
- Interpreting and applying Federal, state, and local policies, procedures and regulations.
- Directing, coordinating assignments of the QA department personnel.
- Establishing and maintaining cooperative working relationships with others.
- Principles of TLMS, leadership, and training.
- Principles of safety, worker’s compensation, OSHA, and related principles and practices.
- Pharmaceutical principles, practices, and their application.
- FDA, SOP, cGMP and other pertinent regulatory compliance and requirements.
- Business and personal computer hardware and software applications.
- Business English usage, spelling, grammar, and punctuation.
- Business, scientific and personal computer hardware and software applications.
- Skill levels in MS Office including proficiency in Word, PowerPoint, Excel and SharePoint.
- Must be able to maintain the highest levels of confidentiality, integrity and discretion.
- Excellent verbal, written, and interpersonal skills required.
- 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.
- Able to identify solutions to general problems through collaboration and creativity.
PHYSICAL REQUIREMENTS:
- Sitting for extended periods of time at work station or mobile equipment
- Walk Operations areas frequently.
- Close visual acuity to perform activities such as computer work, preparing and analyzing data, extensive reading, and 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.
- Exposure to low to moderate noise levels
- Fast paced environment.
- Able to manage multiple priorities and ensure appropriate follow-ups.
- Highly organized and excellent time and project management skills with the ability to juggle a wide range.
- Ability to work under pressure and meet deadlines.
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.
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 [email protected] 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.
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.
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