Senior Compliance Associate
West Chester, United States, Pennsylvania, 19380
Who we are
The opportunity
The Senior Compliance Associate is a key member of the GMP manufacturing team, focusing primarily on deviation investigations and continuous improvement projects. They support a clinical GMP biologics manufacturing facility that produces both bulk drug substance and sterile drug product. This role is a full-time onsite position.
How you’ll spend your day
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.
• Investigate deviations, perform thorough product impact assessments, utilize root cause analysis tools, and work cross functionally to implement effective CAPAs
• Prepare high quality investigation reports and other technical documents
• Ensure timely closure of assigned deviations/CAPAs
• Ensure the manufacturing deviation program is in a controlled state
• Participate in investigation teams for complex or multi-disciplinary deviations.
• Lead and coordinate continuous improvement projects of varying complexity in manufacturing operations
• Other activities related to GMP compliance, production, continuous improvement, or related as determined by Area Management
Your experience and qualifications
Any equivalent combination of education, training and/or experience that fulfills the requirements of the position will be considered.
Minimum Qualifications:
• BS degree in science, engineering, or a related life science field of study with 3+ years of experience in cGMP manufacturing in the pharmaceutical, biopharmaceutical, or biotechnology industry
• 1+ years of experience in root cause analysis, deviation investigation, and technical report writing in a GMP pharmaceutical manufacturing environment
• Excellent written and verbal communication skills
• Basic understanding of Lean Sigma principles and Root Cause Analysis
Preferred Qualifications:
• BS/MS degree in science, engineering, or a related life science field of study with 5+ years’ experience cGMP manufacturing in the pharmaceutical, biopharmaceutical, or biotechnology industry
• Training / certification in deviation investigation and root cause analysis
• 5+ years of experience leading deviation investigations in a pharmaceutical environment.
• 5+ years of experience leading continuous improvement business projects driven by Lean Sigma methodology
• Experience in a pharmaceutical GMP Quality Assurance, Compliance, or Manufacturing Operations role
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.
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.
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 global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, 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.
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.
