Quality Assurance Specialist/Trainer

Plastikon Healthcare is looking for a Quality Assurance (QA) Specialist/Trainer responsible for site training activities, supporting Medical Device and Pharmaceutical product platforms, including final review and approval of all current Good Manufacturing Practice (cGMP) Standard Operating Procedures (SOPs), Forms, Appendixes, Master Batch Records (MPRs), Master Packaging Records (MBRs), and other pertinent documents. This position is responsible for several key systems in support of ISO requirements, including site nonconformance investigations and associated Corrective Action Preventative Action (CAPA), risk assessment, internal audit, technical writing, document control and product release/disposition in coordination with the Quality Review Team (QRT). The position works independently and collectively as part of an integrated team environment with extensive interactions with Quality Control (QC), Manufacturing, Formulation, Maintenance, Engineering and Administrative Departments. The incumbant is also responsible for tracking training, internal audit, nonconformance and CAPA completion and reporting to management on the compliance status of the site on a regular basis.

DUTIES & RESPONSIBILITIES:

• Directly responsible for site training activities, supporting Medical Device and Pharmaceutical product platforms.
• Must be proficient in cGMP standards
• Must be familiar site Standard Operating Procedures (SOPs), Forms, Appendixes, Master Batch Records (MPRs), Master Packaging Records (MBRs), and other pertinent documents in order to develop and conduct employee trainings.
• Responsible for several key systems in support of ISO requirements, including site nonconformance investigations and associated Corrective Action Preventative Action (CAPA), risk assessment, internal audit, technical writing, document control and product release/disposition in coordination with the Quality Review Team (QRT).
• Works independently and collectively as part of an integrated team environment with extensive interactions with Quality Control (QC), Manufacturing, Formulation, Maintenance, Engineering and Administrative Departments.
• Responsible for tracking training, scheduling and conducting employee orientation, and assisting with employee competency evaluations.
• Directly responsible for training system oversight. Enters data in the Training Manager program. Provides reports to managers in support of continued competency of all site employees. Monitors training progress and competency to promote continued employee growth.
• Directly responsible for the continuous improvement of all types of training documents. Be available for involvements in Kaizen events and projects throughout the site.

Job Roles this position may support:

• Document Change Request (DCR) System: Use of the DCR System to change or add new document requirements, aid with technical document writing, coaching site personnel, and move documents through the system for completion. Coordinate the writing and revision of all documents.
• Non-Conformance Report (NCR) System: Participate in the nonconformance system through investigation and reporting of Nonconformances for the site. Provides final reports and communication based on investigation findings.
• QA: Interacting with auditors, including the FDA, when required. Maintains quality service by enforcing organization standards and providing guidance to the site. Actively supports the quality and business requirements of the Quality Systems. Assists with batch audit review and release, as necessary.
• Other duties: As assigned.

EDUCATION / EXPERIENCE:
Minimum Requirements:

• BS in Science, equivalent field
• Minimum 5 years’ experience as a trainer in a GMP pharmaceutical, medical device, or related facility.
• Experience in ISO standard execution is desired.

Skills/Qualifications:

• Excellence in MS Word, Excel, and PowerPoint
• High level of attention to detail with the ability to prioritize and manage heavy workloads in a dynamic environment
• Must have good organizational, presentation, and communication skills

LANGUAGE SKILLS:

• Required reading, writing, and speaking fluently in English

WORK ENVIRONMENT:

• This is largely a sedentary role
• This position operates in a professional office environment and routinely uses standard office equipment

HPJobs#

Job Type: Full-time

Pay: $73,482.00 - $78,166.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 5 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person
• Office

Work Location: In person