Teva QC Specialist 

United States, Pennsylvania, East Bradford Township 

269782566

Travel Requirements: None

Manages outsourcing of QC to vendor (when appropriate).
⦁ Assesses outsourcing needs and resources
⦁ Estimates/revises budgets
⦁ Serves as primary contact for file sharing, queries, and issue escalation, as needed

Mentors and/or trains new or junior QC reviewers to achieve department set goals for excellence in quality review.

Works cross functionally to continuously improve processes.

Requirements:

• PhD, PharmD, Masters degree, or Bachelors degree in English/Life Sciences
• Minimum 3 years of QC experience

Preferred:

• Minimum 5 years in the pharmaceutical or medical industry

Specialized or Technical Knowledge Licenses, Certifications needed:

Proficient in Microsoft Office, Document management systems, hyperlinking and bookmarking

Functional Knowledge:

• The ability to fluently read, write, understand and communicate in English
• Experience in clinical research with proven proficiency in global clinical development
• Ability to understand and interpret complex clinical and/or scientific and statistical data and effectively communicate inaccuracies in technical documents to authors.
• Demonstrate strong medical and/or scientific communications (written)
• Proven ability to work independently to deliver clinical technical document discrepant findings within defined timelines.
• Previous experience in clinical development of clinical technical document deliverables with knowledge in world-wide regulatory requirements for drug and device registration
• Ability to conduct thorough and accurate research, have logical organizational skills, clear readable writing, and adherence to required templates.
• Solid computer technical skills (Word/Excel/PDF development), ability to acquire skills in accordance with company and external writing standards, and learn new systems quickly.
• Strong knowledge of global regulatory requirements
• An understanding of the clinical drug development process, including clinical trial design, operations, and results analysis

Company/Industry Related Knowledge:

• Knowledge of global regulations/guidelines for document submissions and authoring styles (eg, AMA)

Job-Specific Competencies:

• Excellent English, both written and spoken
• Excellent interpersonal skills, written and verbal communication skills, and administrative skills
• Leads process development and improvement
• Tackles difficult problems; Identifies solutions and recommends action to management
• Manages and delivers assignments with quality and within timelines
• Provides input for budget planning
• Attention to detail is a must
  

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 holiday.
• 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.
The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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