Job Description
We are passionate about our employees. We strive to create an environment that is stimulating and motivating and a culture that fosters mutual respect, teamwork, and career development. Come join the Keystone team so we can build your career together!
In addition to competitive starting salaries, we offer a wide variety of competitive benefits, perks and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
Please visit our website at www.keystoneind.com to learn more about Keystone Industries and career opportunities.
Position Details:
Coordinate activities required to direct and control manufacturing quality. Support or oversee the Quality Unit (QU) activities as required by FDA 21CFR Parts 210/211 and 820, including but not limited to the essential functions, listed below.
Essential Job Functions:
- Provide, and oversee, inspection activity for cosmetic finished goods, as well as drug and medical device products throughout their product cycle. Perform appropriate customer complaint and product nonconformance follow-up and close-out activities including Product Conformance and Out-of-Specification (OOS) Investigations, Corrective / Preventive Action Requests, Nonconformance Product Reports, etc.
- Under QU Management guidance, continuously review department processes, procedures, and capabilities to sustain the most cost-effective and efficient methods for meeting quality requirements; suggest recommendations for improvement as appropriate.
- Assist with the authoring and revision of procedures, batch cards and specifications impacting the identity, strength, quality, and purity of drug and medical device products. Ensure procedures are appropriate, implemented, trained to, and consistently followed. Ensure any deviations from established procedures are recorded and justified.
- Participate in regulatory agency & other third-party audits/inspections & associated Nonconformance closures.
- Conduct or oversee validation activities, such as sample collection and shipment.
- Responsible for reviewing contract QC, cleaning validation & stability lab data, documentation related to test method validation, requesting rework, OOS Investigation, and resolving lab related issues.
- Oversee label control system/functions.
- Coordinate with external and internal laboratories for product testing. Assist with the approval of testing invoices.
- Participate in projects related to quality system improvement. Work independently or under minimal supervision of QU Manager to provide periodic updates, and furnish reports and/or presentations, and ensure adherence to deadlines.
- Initiate the ordering of chemicals, consumables, and equipment as necessary. Verify that equipment is maintained and calibrated appropriately.
- Participate in graphic art QC approvals.
- Assist in conducting vendor assessments.
- Serve as a senior resource for the Quality Unit team, offering guidance, training, and mentorship to support team development and collaboration.
- Assign supplemental projects to team members and help monitor progress.
- Contribute input to performance feedback and development discussions for team members.
- Ability to provide coverage for Quality Unit functions in the absence of Quality Unit staff, including completion of on‑floor inspections and related quality activities.
- Perform additional duties/tasks as needed or requested by management.
Qualifications:
- Minimum 5 years’ directly related experience.
- Experience working with chemistry, biology, math, or another related technical field and/or working within the pharmaceutical industry.
- Strong knowledge or background in a manufacturing Quality Control/Assurance environment.
- Demonstrated knowledge of FDA CFR 210 & 211, cGMP Pharma requirements.
- Demonstrated knowledge of FDA CFR 820 / ISO 13485 cGMP Medical Device requirements.
- Exceptional computer skills, including Microsoft Office Suite; Ability to learn and leverage new systems.
- Proven ability to perform under deadlines, to adjust plans to meet changing needs and requirements.
- Excellent oral, written, listening, and presentation skills and ability to clearly articulate complex information to others.
- Strong attention to detail, demonstrated integrity and professionalism.
- Must be an effective team player.
- Self-starter, strong initiative, dependable and capable of following through with minimal supervision.
- Ability to effectively train, engage, and motivate.
Desired Skills:
- Experience in leadership or supervisory role.
- Experience in a manufacturing environment.
- ERP/MRP software experience.
- QMS experience.
Education/Certifications:
- Bachelor’s Degree in Technical/Science/Chemistry or related field. Other degrees will be considered with relevant job experience.
Safety:
- Comply with all safety regulations; maintains a safe work environment at all times
- Adhere to always wearing the proper PPE/Safety equipment.
- Understand and comply with all written safety, health, and environmental procedures.
- Attend all required scheduled Health, Safety and Environmental training sessions.
- Participate in required Health, Safety and Environmental initiatives and programs.
- Perform required administrative functions related to Health, Safety and Environmental functions such as completing forms, checklists, and log sheets.
Physical Demands and Work Environment:
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- Physical Demands: Employee is required to walk; stand; sit; use hands and fingers to manipulate objects, tools, or controls; reach with hands and arms to operate a computer and other office equipment, and occasionally lift/move up to 25 lbs. Minimal need to balance, stoop, bend, kneel or climb.
- Work Environment: This position is located in an office setting, within a manufacturing facility. Noise intensity level: quiet to low. Employees may occasionally need to enter manufacturing or lab areas, including cleanroom environments, which may include exposure to moderate noise, moving equipment, and hazardous contaminants. When entering these areas, employees must adhere to all applicable safety protocols, including Personal Protective Equipment (PPE) and/or gowning requirements. Occasional travel may be required for audits, inspections, site visits, customer meetings or events, and industry conferences.
