We are seeking a Quality Operations Leader for our First Quality Retail Services facility located 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 opportunitiesPaid time off (three-week minimum)Medical, dental and vision starting day one401(k) with employer matchPaid parental leaveChild 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 assistanceWellness 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.