Praxis Packaging continues to grow! We are investing in new lines and production capabilities. As such, we are seeking an experienced, Professional Quality Facility SR Specialist to join our team! The Quality Facility Sr. Specialist will work with all departments and teams to ensure compliance with requirements of 21CFR Part 211 section 211.22 (a) (c). Work with all supervision and employees to ensure that cGMPs and Praxis’ SOPs, policies and work instructions are being followed. Maintain policies and quality standards on all aspects of cGMP facility compliance.
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Essential Functions and Responsibilities:*

• Assist in ensuring Production, Warehouse and all other facility areas are maintained in a state of compliance and control.
• Provide support and oversight of cleaning activities associated with all equipment and room cleaning.
• Provide and perform cleaning activities to ensure adherence to all cleaning procedures.
• Provide support with cleaning verification for primary fill packaging operations per established Standard Operating Procedures (SOPs).
• Conduct process audits throughout the facility to ensure compliance to all facility and hygiene cGMP standards.
• Ability to develop and update efficient documentation of work procedures (Standard Operating Procedures, Work Instructions, Forms, Job Aids, Templates)
• Support management with an incident and/or deviation, by investigating, documenting, reviewing/or approving and escalating issues as appropriate to the team.
• Ability to demonstrate strategic and critical thinking capability with strong project management skills, focus on decision execution, while balancing conflicting priorities.
• Provide timely notifications to the customer/supplier for incoming quality related issues as needed.
• Track and trend metrics for key quality performance indicators for cross-functional visibility.
• Support all Packaging operations cradle to grave to ensure facility and hygiene cGMP compliance.
• Provide in-depth knowledge of governing regulations of packaging, labeling, serialization, etc. of pharmaceutical, medical devices, food and combination products and have the ability to apply it to overall site compliance with respect to facility hygiene and all associated practices.
• Ensure compliance with regards to the Pest Management Program, REES temperature monitoring program, HACCP plans, Gowning, PPE, site cleanliness and any other related activities.
• Subject Matter Expert (SME) in regulatory requirements, expectations, specifications, procedures/processes, manufacturing technology, and/or quality assurance with regards to maintaining a cGMP facility.
• Flexibly works other shifts, shifts maybe 8, 10 or 12 hours as needed.

Knowledge & Experience:

• Bachelor Degree, required or equivalent combination
• 3 years Quality experience with (cGMP, QA systems, deviations, and audit) required
• Experience in food, medical device, pharma and manufacturing industry, required
• Experience in working with various levels of employees with different educational backgrounds, work style habits, and employment histories.
• 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 MS Office programs: Word, Excel, and Outlook, preferred
• Working knowledge of Enterprise Resource Planning (ERP) related software, preferred
• Working knowledge of QMS Software Systems (TrackWise, ETQ, Intellex etc..), preferred
• Ability to present training topics to small or medium sized groups
• 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

About Praxis Packaging:
Established in 1989 and headquartered in Grand Rapids, MI, Praxis Packaging Solutions is a full service contract packaging company specializing in Secondary Packaging operations for the consumer product, cosmetics, food & beverage, over the counter (OTC) and prescription (Rx) pharmaceuticals, and promotional products industry as well as Primary Filling and Packaging of Oral Solid Dosage Tablets.

We are an independently operated subsidiary of the Huizenga Group. The Huizenga Group is a privately held firm that provides management services to a diverse group of companies. The current portfolio of companies provides products and services for the world adding automotive, pharmaceutical, military goods, medical device, consumer goods and office furniture manufacturers.
Our company provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics.

Job Type: Full-time

Pay: From $75,000.00 per year

Schedule:

• Day shift

Work Location: One location

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