Quality Assurance Specialist
Position Overview: The Quality Assurance (QA) Specialist is tasked with reviewing a variety of documents, protocols, qualifications, and reports related to Quality Management Systems. This position involves interaction with clients regarding quality issues as needed. The QA Specialist may also participate in regulatory inspections, client audits, and internal audits.
Key Responsibilities:
- Adhere to all company policies, procedures, work instructions, and training requirements.
- Assist in developing quality assurance policies, procedures, standards, processes, and new models.
- Support the Production department with process validation and equipment/facility qualifications.
- Aid in the complaint management process by reviewing, investigating, and preparing responses to complaints from customers or third parties.
- Assist the QA/R Manager with root cause analysis and corrective actions related to complaint investigations.
- Help with new supplier approvals as part of the supplier approval program.
- Review nonconforming products and recommend appropriate actions.
- Maintain, control, and distribute controlled documents and records related to the Quality Management System.
- Write procedures, work instructions, and specifications related to the quality management system.
- Perform and document monthly and quarterly monitoring of cleanroom and warehouse environments.
- Conduct and document qualification, calibration, and re-certification of cleanroom and equipment.
- Prepare reports, analyze data, and assist Quality Management in developing action plans to achieve departmental benchmarks.
- Provide ongoing support for the daily activities of the Quality Assurance team and work with Quality Management to ensure daily goals and metrics are met.
- Act as a support function to the Quality Assurance Associate as needed.
- Perform other related duties as assigned.
Required Skills/Abilities:
- Strong written and verbal communication skills
- Excellent root-cause analysis, problem-solving, and analytical skills
- Strong organizational skills and attention to detail
- Teamwork and collaboration abilities
- Proficiency in using measuring devices such as gauges, meters, calipers, and computers
- Ability to understand product drawings, specifications, and visual work instructions
- Documentation and reporting skills
- Effective communication with technical staff, production teams, and leaders
- Basic computer skills (MS Word, MS Excel, MS Outlook)
- Proficiency in reading, speaking, and writing in English
Experience:
- 3-5 years of current experience in the medical device and/or pharmaceutical industry
- Prior experience in an FDA-regulated environment is preferred
Physical Requirements:
- Ability to stand, sit, stoop, kneel, crouch, stretch, and reach with hands
- Must be able to lift and move up to 50 lbs.
