CAREER PORTAL

Quality Systems and Document Control Specialist

Quality Systems and Document Control Specialist  needed for a contract opportunity with Yoh Scientific’s client located in  Philadelphia, PA.
 
This position requires a  Bachelor’s degree   in Life Science or another related field and 2+ years of experience in the biotechnology/pharmaceutical industry. Schedule is  full-time M-F (7am-8am start time, 8 hour shift)  and may require flexibility to work some evenings and overtime due to projects.
 
Primary Duties:
This position will support deviation evaluation, root cause analysis, laboratory investigations, and development and implementation of Corrective and Preventive Action Plans (CAPAs). This position is also responsible for supporting the Quality Document Control program and ensuring compliance to quality objectives and regulatory requirements.
 
Key Responsibilities:

• Ensure document periodic reviews occur within the required time frames.
• Provide owners of Periodic Review Tasks and Documents due for Periodic Review with constant transparency into target due dates.
• Perform timely processing of new documents & document revisions in the Quality Management System (QMS) (from Change Request, processing and assigning author approvals to setting the documents effective).
• Generate and issue out controlled copies of documents, including but not limited to Logbooks and Batch Production records.
• Ensure Deviations & CAPA close out within the required time frames.
• Review and QA Final Approve investigations, ensuring root cause is identified and risk assessment is captured in detail. Also ensure appropriate CAPA has been launched in response.
• Review and approve CAPA plans and CAPA Effectiveness Checks.
• Review and approve Deviation & CAPA Extension Requests.
• Perform review & final QA Approval of Supplier & Product Complaints.
• Provide investigators and CAPA owners with constant transparency into target closure dates.

 
Qualifications:

• Bachelor’s Degree in Life Science or another related field.
• Prior experience in Quality Assurance / cGMP / FDA regulated industry.
• Prior experience with Master Control strongly preferred but any QMS/DMS/LMS background acceptable.
• Knowledge of Deviation Root Cause Investigation and Risk/Impact Assessment.
• Knowledge of CAPA and Effectiveness Checks.
• Proficiency in MS Office applications.
• Proficient with MS Office software (Word, Excel & Power Point) Excellent interdepartmental, technical writing and verbal/written communication skills.
• Must have proven interpersonal skills and be able to supervise the activities of subordinates.
• Ability to work in a fast-paced environment, prioritize task completion and be able to work with high degree of independence once trained a must.

 

Estimated Min Rate: $38.00
Estimated Max Rate: $43.00


What’s In It for You?
We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.