Compliance Specialist II (Manufacturing/Quality)

job summary:

As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!

location: Northborough, Massachusetts
job type: Contract
salary: $45.00 - 47.74 per hour
work hours: 9 to 5
education: Bachelors


responsibilities:

• Ensuring that activities within scope are conducted in compliance with applicable regulatory requirements
• Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations
• Perform finished product inspections according to standards, specifications established timelines
• Perform AQL inspections according to standards, specifications established timelines
  Trend AQL failures according to standards, specifications established timelines
• Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)
• Manage the sampling, storing, monitoring and maintenance of finished product retention samples according to standards, specifications and established procedures and timelines
• Manage / perform annual inspection of retention samples
• Support creation of new material and product specifications
• Perform document creation/revision, including periodic reviews, for department documentation according to established procedures and scheduled timelines
• Support department Quality Management System (Change Control, Deviations, CAPA)
• Support department documentation archival system
• Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor
• Managing / escalating and resolving quality-related issues in a timely and effective manner
• Support the monitoring and analyzing of quality performance metrics, implementing corrective actions as needed
• Support root cause analysis investigations for quality incidents and implementing preventive measures
• Support quality walkthroughs
• Participating in internal and external audits and regulatory inspections providing support and documentation, as well as speaking as a subject matter expert in area of focus
• Support risk management strategies to mitigate potential quality issues
• Fostering a culture of quality and continuous improvement across the organization
• Key Roles- Request corrections when GMP rules are not respected
• Prioritize quality and compliance objectives
• Request quality improvement initiatives and strategies
• Identify discrepancies and corrective/preventive actions that need to be taken
• Escalate to upper management any failure in GMP execution on shopfloor
• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures
• Advise on how to present a topic and answer specific questions
• Advise on risk management strategies and plans
• Advise on initiatives to promote a quality-focused culture

qualifications:

Must have Skills:

- Bachelor's degree (Masters and PHD's will be accepted)

- 3 Year experience in related role (more experience the better)

- Quality Shop floor experience, quality assurance review experience

- Experience with inspecting finished goods and product

- Previous pharma and biotech experience / GMP (strongly preferred)

#LI-MT1

Nice to have:

- Change Control, Deviations, CAPA (strongly preferred)

- SAP, Veeva

skills: Veeva Vault, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA)


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.