Quality Operations Leader
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 :
- 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 allVerifies communication of process changes and quality procedure / specification changesSupports support teams with all key initiatives, special projects and provides exceptional customer serviceFacilitates and leads communication in group settings and / or meetingsInterfaces with other departments in discussions relating to qualityPerforms laboratory tours and provides quality system explanations to visitorsAssists in communication and training of quality conceptsProvides recommendations for improvements to the quality system, testing methods and equipmentAssists with internal audits of the quality systemSafety 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 practicesAssures personal participation and team verification for 100% compliance of :Monthly Safety Committee Meeting attendance, safety training in the LMS & safety auditsQuarterly safety observations, safety training in the LMS, & safety auditsAs needed safety incident reporting & related follow up action items (CAPA)People Leadership
Lead Self
Understands and models the values and culture of the companyKnows oneself and understands leadership impactModels transparency and learns from mistakesCourageously aligns words and actionsServes as a positive team player that works to find solutions and builds team moraleOwns and participates in self-development opportunitiesLead Others
Leads, coaches and mentors team members to achieve quality goalsHelps select and develop great teamsCoaches, listens, and engages in direct dialogueEmpowers others and models accountabilityBuilds trusting and caring relationships with all team membersLeads cross-company teamwork and collaborationDrives execution on completion of tasksCompletes on time, well-written reviewsProvides continuous feedback to team membersLead Forward
Inspires others and is optimistic about the futureThinks critically and acts strategicallyEvaluates team member work assignments & optimize where necessaryChampions change to grow the businessBusiness Management & Administrative Responsibilities
Quality Management
Leads and maintains proper housekeeping in the lab and at test stationsCoordinates lab support for data collection and analysis in product capability and process validation studiesDevises and revises standard operating procedures related to the quality systemPerforms, understands, and trains quality testing methods and quality requirementsEnsures that all testing and measuring equipment is calibrated and maintained according to proceduresTime Management & Administration
Assists in time and attendance record keepingUtilizes and maintains Outlook calendar to organize individual's schedule, meetings, and eventsMaintains and orders laboratory suppliesPerforms laboratory tours and provides Quality System explanations to visitorsThe 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 capacityStandard 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 skillsStrong analytical and problem-solving skillsMust be able to work in a fast-paced environmentWhat 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!