Quality Operations Leader I

We are seeking a Quality Operations Leaderfor our First Quality Retail Services facilitylocated in Lewistown, PA This position will be responsible for the supervision of QA and QC technical staff and directs the plant quality lab function to assure procedures are developed, implemented, and adhered to in order to meet company objectives and customer requirements. Also responsible for the quality review of all aspects of manufacturing.

Primary responsibilities include:

• General Responsibilities
  
  
  • Follows and ensures accountabilities for all necessary regulations (i.e.: GMP, FDA, and ISO)
  • Oversees proper use and control of production and QA department quality records
  • Directs the development, training, scheduling, and functions of assigned QA/QC technical staff
  • Performs and understands quality testing methods and quality requirements
  • Maintains lab equipment and oversees the calibration program
  • Performs other duties as necessary when directed to do so
  
  
  Communication/Collaboration Responsibilities
  • Ensures proper communications and schedule changes to all
  • Verifies communication of process changes and quality procedure/specification changes
  • Supports support teams with all key initiatives, special projects and provides exceptional customer service
  • Facilitates and leads communication in group settings and/or meetings
  • Interfaces with other departments in discussions relating to quality
  • Performs laboratory tours and provides quality system explanations to visitors
  • Assists in communication and training of quality concepts
  • Provides recommendations for improvements to the quality system, testing methods and equipment
  • Assists with internal audits of the quality system
  Safety Leadership
  • Demonstrates and verifies 100% compliance of safety best practices with team members (PPE, LOTO, cleaning, no jewelry, loose fitting clothing, etc.)
  • Drives a zero-loss time mentality with team through continuous improvement practices
  • Assures personal participation and team verification for 100% compliance of:
  • Monthly - Safety Committee Meeting attendance, safety training in the LMS & safety audits
  • Quarterly -safety observations, safety training in the LMS, & safety audits
  • As needed - safety incident reporting & related follow up action items (CAPA)
  
  
  People Leadership - lead authentically with a passion and capability to transparently engage, motivate, and move people toward the achievement of our desired state
  
  Lead Self
  • Understands and models the values and culture of the company
  • Knows oneself and understands leadership impact
  • Models' transparency and learns from mistakes
  • Courageously aligns words and actions
  • Serves as a positive team player that works to find solutions and builds team morale
  • Owns and participates in self-development opportunities
  
  
  Lead Others
  • Leads, coaches and mentors team members to achieve quality goals
  • Helps select and develop great teams
  • Coaches, listens, and engages in direct dialogue
  • Empowers others and models accountability
  • Builds trusting and caring relationships with all team members
  • Leads cross-company teamwork and collaboration
  • Drives execution on completion of tasks
  • Completes on time, well-written reviews
  • Provides continuous feedback to team members
  Lead Forward
  • Inspires others and is optimistic about the future
  • Thinks critically and acts strategically
  • Evaluates team member work assignments & optimize where necessary
  • Champions change to grow the business
  
  
  Business Management & Administrative Responsibilities
  
  Quality Management
  • Leads and maintains proper housekeeping in the lab and at test stations
  • Coordinates lab support for data collection and analysis in product capability and process validation studies
  • Devises and revises standard operating procedures related to the quality system
  • Performs, understands, and trains quality testing methods and quality requirements
  • Ensures that all testing and measuring equipment is calibrated and maintained according to procedures
  Time Management & Administration
  • Assists in time and attendance record keeping
  • Utilizes & maintains Outlook calendar to organize individual's schedule, meetings, and events
  • Maintains and orders laboratory supplies
  • Performs laboratory tours and provides Quality System explanations to visitors

The ideal candidate should possess the following:

• Minimum of two years of college courses (preferred)

• Minimum of one to two years of experience in a leadership capacity

• Standard knowledge of a Quality System (ISO 13485 FDA21 CFR Part 820, GMP/QSM, etc.) (preferred)

• ASQ Certification or equivalent training (CQT, CQA, or CMI).

• Experience with Microsoft Office (specifically Outlook & Excel)

• Excellent oral and written communication skills, computer skills, reasoning, and mathematical skills.

• Strong analytical and problem-solving skills

• Must be able to work in a fast-paced environment

What We Offer You

We believe that by continuously improving the quality of our benefits, we can help to raise the quality of life for our team members and their families. At First Quality you will receive:

• Competitive base salary and bonus opportunities
• Paid time off (three-week minimum)
• Medical, dental and vision starting day one
• 401(k) with employer match
• Paid parental leave
• Child and family care assistance (dependent care FSA with employer match up to $2500)
• Bundle of joy benefit (year's worth of free diapers to all team members with a new baby)
• Tuition assistance
• Wellness program with savings of up to $4,000 per year on insurance premiums
• ...and more

Number of Openings: 1

Req #9804

The closing date to apply will be: 10/01/2025

First Quality is committed to protecting information under the care of First Quality Enterprises commensurate with leading industry standards and applicable regulations. As such, First Quality provides at least annual training regarding data privacy and security to employees who, as a result of their role specifications, may come in to contact with sensitive data.

First Quality is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identification, or protected Veteran status.

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