Qa Associate Jobs

• Perform QA document control activities including processing of change requests, manufacturing records.
• Determine root cause and potential preventative/corrective actions. Ensure support for the timely closure of investigations.
• Review and approve executed inspection and production related documentation.
• Additional duties as assigned.
• Responsible for the execution of remediation/CAPA activities.
• Create and establish processes and procedures to ensure compliance and adherence to regulated QA activities for Medical Device industries.
• Ensure adherence to SOPs, proper change controls, corrective action and preventative action plans, deviation management, impact assessments for changes to equipment and processes, risk management, and ensure documentation and investigations meet regulatory requirements.

Requirements

• Excellent technical writing skills, and experience with standard operating procedures and additional industry regulated documentation.
• Experience with remediation plans with strong knowledge of CAPA activities.
• Knowledge of preventative/corrective actions and deviation management.
• Advanced knowledge of cGMP standards.
• Document control experience.
• Minimum of 2 years of experience in quality assurance within the medical device industry.
• Strong organization skills with the ability to prioritize and multitask.
• Ability and willingness to travel are preferred.
• Bachelors degree in a related field.
• Excellent communication skills both written and verbal.
• Excellent analytical and problem solving skills.

Benefits

• PTO, Sick Time, and Paid Holidays
• Financial Perks and Discounts
• Discounted rate at Anytime Fitness
• Education Assistance
• Pet Insurance
• Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
• Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
• 401(k) and 401(k) matching