Support the plant Quality System to manufacture medical devices and OTC drug products. Responsible for Leading and Directing QC Technicians, maintenance of in process and finished products and raw material quality records and testing procedures, informing stakeholders of quality issues, and compliance with Good Manufacturing Practices and Standard Operating Procedures.
- Supervision of QC Technician staff. This includes scheduling, approving time records, periodic evaluation, counseling, and performance documentation. Responsible for conducting departmental and job specific training.
- Ensure that in process testing is performed by QC per procedural requirements.
- Notify key stakeholders of identified issues and ensure that it is communicated to the right person in a timely manner.
- Provide technical support for resolution of quality problems with operations.
- Develop and maintain QC related documents (WI, QP, form etc.) required for production.
- Ensure work instructions, SOPs, procedures and other pertinent documentation is up to date. Recommend revisions on QC related work instructions as needed.
- Participate in quality complaint investigations. Verify corrective action completion and continued conformance.
- Perform and/or participate in internal and third-party audits while ensuring compliance to internal quality policies and applicable local regulations.
- Additional responsibility as a back-up for Quality Assurance functions:
- Documentation review (i.e. DHR, test results)
- Verification of outgoing international shipments
- Verification of incoming and outgoing sterilization shipments
- Certificate of Analysis (COA) creation and its approval
- International shipment documentation sent to shipper and/or receiver as requested
- For Canadian shipments, send all required documentation to Canadian warehouse
Directly supervises at least 12 to 20 employees in the Manufacturing. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Skills & Requirements
- Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
- Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
- Oral Communication - Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
- Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Able to build morale and group commitments to goals and objectives;
- Delegation - Delegates work assignments; Matches the responsibility to the person; Gives authority to work independently; Sets expectations and monitors delegated activities; Provides recognition for results.
- Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.
- Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.
- Ethics - Treats people with respect; Keeps commitments; Works with integrity and ethically; Upholds organizational values.
- Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; Supports organization's goals and values.
- Strategic Thinking - Develops strategies to achieve organizational goals; Understands organization's strengths & weaknesses.
- Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
- Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
- Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The skill and competency requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Minimum 2-3 years of quality control experience, supervising a team.
- Knowledge of relevant cGMP Standards
- Experience in a plant environment preferred
- QC experience in food, medical device, or pharmaceutical industry
- Knowledge and experience with a variety of quality management systems
- Demonstrated experience leading and developing a team
Knowledge and Education:
- Bachelor’s degree from an accredited institution in Food Science, Chemistry, Biochemistry, Microbiology, or similar.
NeilMed offers Health, Dental, and Vision Coverage, we also have 401K plans and Life Insurance. Vacation, Holiday and Sick Leave are all included in the first full year of employment.
How to Apply
1. Email your resume to email@example.com and include the job title in the subject line of the email
2. Any questions or for more information please text or call #707.530.5256