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Quality Assurance Associate

2 months ago

Andover, United States LanceSoft Full time

Job Description: Position Description

Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve
You will be a member of ***'s dedicated and highly effective quality assurance team. You will be responsible for providing Quality Assurance support to GMP clinical manufacturing. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. In addition, this position will perform a range of duties associated with records management to ensure compliance with regulatory requirements and company standards.

How You Will Achieve It
- Review and approve various Good Manufacturing Practices records (primarily batch records, formulation records).
- Ensure that all documents for batch release are reviewed for completeness and accuracy.
- Support the site relative to a constant state of inspection readiness.
- Recognize when an issue is beyond your sphere of influence and escalate immediately.
- May participate in the release of raw materials, as needed.

BASIC QUALIFICATIONS
Must-Have
- Bachelor's Degree

Nice-to-have
- Experience in pharmaceutical industry

PHYSICAL/MENTAL REQUIREMENTS
- Mental agility to handle a large quantity and broad scope of different types of quality assurance work.
- Ability to work independently, problem solve and make recommendations for solutions.
- Role is primarily office-sitting. Position requires walking, sitting, standing, and carrying batch records from one location to another as Andover site is a campus setting.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- 1st Shift, Monday - Friday, typically 8am -5pm (flex on times)
-Work Location Assignment: Andover, MA. On Premise

Interviews: Teams Meeting
Employee Benefits:

At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits. (To be bought)

  • Four options of Medical Insurance
  • Dental and Vision Insurance
  • 401k Contributions
  • Critical Illness Insurance
  • Voluntary Permanent Life Insurance
  • Accident Insurance
  • Other Employee Perks
About LanceSoft
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.
EEO Employer
LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time