Job Details
Overview:
We have an immediate opening for a Quality Support position in our Quality Department. This role will be responsible to assure compliance with the requirements of 21CFR Part 211 section 211.192 which states that all drug product production and control records shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. This role works closely with the Account Managers, Customer Service, Production, Quality Operations and Warehouse to assure all job-related paperwork complies with regulatory and customer requirements and supports the Quality System Manager and team by supporting key Quality System Programs, including a selection of the following: Document Control, Change Control, Records Control, Internal and External Audits, Food Safety compliance, Annual Product Reviews, Regulatory Filings, and Continuous Improvement initiatives.
Responsibilities:
Essential Functions and Responsibilities:
- Serves as mentor/trainer to new Work Order Compliance Specialist members.
- Ability to demonstrate strategic and critical thinking and focus on decision execution, while balancing conflicting priorities.
- Provides technical assistance to WOC Specialists.
- First responder problem solver with Quality Batch Record related issues.
- Assists with Orientation and GDP/Data Integrity training.
- Assists with reviews of final Batch Record paperwork for accuracy.
- Ensure any job paperwork is corrected in a timely manner.
- Complete job paperwork as needed.
- Ensure Customer yield requirements are met.
- Provides timely responses to the customer for any Batch Record related issues and questions.
- Tracks and trends metrics for key quality performance indicators for cross-functional visibility.
- Performs Quality inspections and batch record review as assigned.
- Supports management with an incident and/or deviation, by investigating, documenting, and escalating issues as appropriate to the team.
- Ability to demonstrate strategic and critical thinking and focus on decision execution, while balancing conflicting priorities.
- Assists with processing document control changes to SOPs, Work Instructions, Packaging Specifications and Forms, upon request.
- Ensures all controlled documents comply with Praxis approved format(s).
- Assist with filing, logging and retiring completed Document Control and Batch Records in the Quality Records area, as directed by Praxis
- Procedures.
- Assist with External Audits preparations and War Room assistants on audit days.
- Files, Logs and retires full or obsolete Major Equipment and Portable Equipment Logbooks after they have been verified by the Quality.
- Assist with Annual Product Reviews (reports) for each finished good variant sold (when required by Quality Assurance Agreement) as assigned.
- Collects data for Quality Systems Management.
- Cross-functional assistance within the Quality Systems duties.
- Ensures employees are trained according to their roles.
- Responsible for adherence to all Company policies and procedures.
- Ensures proper PPEs and Safety procedures are followed.
- Works to improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions.
- Instills a sense of quality through modeled quality behaviors and mindset.
- Adherence to all Company policies, procedures, cGMPs, and regulatory requirements.
- Flexibly works other shifts, shifts maybe 8, 10 or 12 hours as needed.
Performs any other functions and duties assigned as necessary for the smooth and efficient operation of Praxis Packaging Solutions.
Qualifications:
Knowledge & Experience:
- High school diploma or equivalent required.
- Associates Degree or equivalent combination preferred.
- 4 years plus of similar experience, required.
- In-depth knowledge of governing regulations of packaging, labeling, of pharmaceutical.
- 2-3 years of GDP/GMP experience required.
- The ability to work independently, without supervision required.
- Ability to organize priorities and workload required.
- Ability to work and communicate with cross-functional teams.
- Ability to demonstrate critical thinking.
Computer/Communication Skills:
- Working knowledge of Enterprise Resource Planning (ERP) related software, preferred.
- Ability to speak, read and write English in a manner that is sufficient for effective communication with supervisors, employees, and customers: to include reading and writing skills to understand and complete necessary customer paperwork, required.
Physical Requirements and Work Environment
Regularly required to walk, stand, bend, twist, reach with hands and arms, stoop, kneel and crouch. Raise and lower an object from one level to another, less than 30 lbs. Good (corrected) eyesight and hand/eye coordination. Normal office environment with little exposure to dust and weather conditions prevalent at the time (i.e., cold, hot/humid). May also require visits to production area where employee may be exposed to moving mechanical parts, dust and weather conditions prevalent at the time (cold, hot/humid). Must be able to work full time. 8, 10, or 12 hours, 1st, 2nd, and 3rd shift.