QA Specialist / Trainer - Pharmaceutical
Location
Lawrence, KS | United States
Job description
Our client – a growing company with multiple plants in the US, needs a QA Specialist – Trainer at their KS plant expanding to manufacture pharmaceutical products. Excellent salary up to $90K + Relocation assistance + Full Benefit Package.
Job Posting # 2622
Job Title : QA Specialist / Trainer - Pharmaceutical
Location: Lawrence, KS
Compensation: Salary of $70K - $90K per year
Relocation: YES - Client offers relocation assistance and payments for expenses
Benefits: Full package for medical, dental insurance, 401K, etc.
This is a privately held company in business for 40 years with 300 people at manufacturing sites in CA, KS
Group Info: Be part of the medical device and pharmaceutical contract manufacturing site with around 100+ employees and expected to grow to 150 people soon due to major expansion in Pharma manufacturing .
The new operation expansion is for Pharma - Blow Fill Cap – BFC of Sterile Solutions.
The Quality group has around 25 people from QC, QA, Quality, Validation, Compliance. This role will report to the Director of Quality . This person will work independently and report to the Director of Quality
Job Summary:
This new Quality Specialist – Trainer role will be in charge of all Quality Training functions
Job Description:
- Directly responsible for site training activities, supporting Medical Device and Pharmaceutical products
- Must be proficient in cGMP standards
- Must be familiar site Standard Operating Procedures (SOPs), Forms, Appendixes, Master Batch Records (MBRs), Master Packaging Records (MPRs), 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.
- 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.
Candidate Must Have :
- BS Degree in Science
- Min. 5 years of Trainer experience in cGMP regulated Pharma or Medical Devices
- 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
Candidate Nice to Have:
- Technical degree in Science, Chemistry, Biology, Microbiology or Engineering
- Experience in ISO standard execution is desired.
- Startup or Small company experience working in a dynamic and hands-on role.
- Knowledge of Sterile Aseptic Filling Operations
- Contract Manufacturing experience working closely with customers and clients
Keywords: BioPharma, Pharma, Quality, ISO, FDA, Trainer, QA, QC, CMO, Sterile Aseptic, filling,
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