What are the responsibilities and job description for the Manager, Quality Operations position at Sharp Clinical Services?
The Manager, Quality Operations is responsible for the activities of the Quality Operations team at the Sharp Clinical Bethlehem site. This role ensures continuous receipt and production of product in accordance with product specific quality specifications and procedures. He/She assists in the maintenance of company policies and procedures to ensure regulatory compliance. He/She is responsible for training, development, motivating and counseling of subordinate staff, estimating staffing needs, assigning work, meeting completion dates, interpreting and ensuring consistent application of organizational policies. He/She effectively communicates and may conduct a variety of personnel actions; e.g., hiring, performance and salary reviews, disciplinary actions, scheduling and/or approving overtime and separation.
Essential Duties and Responsibilities
- Manages Quality Operations (Production, Warehouse) employees, tasks and duties related to quality within the organization.
- Troubleshoot and direct the resolution of Quality issues related to Packaging, Manufacturing and Warehouse by fostering effective interdepartmental and cross-functional partnership
- Develops, implements and assesses processes and policies designed to test products and services.
- Monitors and evaluates current testing processes, making recommendations for improvements when necessary.
- Understands and enforces quality, regulatory and safety compliance as related to the company procedures and law.
- Monitors the performance of the quality operations staff against organizational objectives.
- Provide coaching and feedback regularly to team members as well as conduct performance evaluations in a constructive and timely fashion.
- Directly supervise the work activities of employees engaged in quality inspections over multiple operating shifts to assure that products and processes meet company and regulatory requirements/standards.
- Review, investigate, report and assist in the identification of product nonconformances. Assist with corrective actions to preclude the recurrence of similar issues.
- Track and monitor key process indicators related to Quality Operations and implement programs designed to increase department and company employee awareness and knowledge of product nonconformities.
- Ensure non-conforming product is properly segregated and quarantined, products are properly identified with product status in accordance with company procedures and the results of all inspections are properly documented using good documentation practices in accordance with company policies and procedures.
- Troubleshoot problems with QC testing equipment and assurance to calibration standards.
- Assure efficient and economical utilization of materials and continuous improvement of methods to eliminate wasteful practices within the functional group.
- Identify and implement quality system improvements when gaps are identified through audits and departmental reviews.
- Follow all applicable cGMPs, FDA, DEA, OSHA, and IATA Regulations, and ISO guidelines.
- Adhere to set safety standards.
- Participate actively in regular meetings.
- Achieve expected performance measures.
- Other duties as assigned.
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- Bachelors’ Degree, Associates Degree, or equivalent in science or technical related field preferred.
- Minimum 5 years relevant work experience in a cGMP environment
- Advanced knowledge of GMPs, GDPs, Quality Assurance/Quality Control skills and the ability to communicate this knowledge to the organization professionally and succinctly
- Demonstrated ability to work independently, handle multiple tasks simultaneously, negotiate and meet critical timelines, strong attention to detail and excellent organizational skills.
- Experience with Microsoft Office applications and quality management systems
- The ability to make sound regulatory interpretation, employ logic, and implement decisions from within the Quality organization
- Demonstrated ability for effective communication, teamwork, and problem solving skills
- Quality experience in an operational or development setting with demonstrated knowledge of techniques for assessing the quality of processes and the ability to guide others in these activities.
- Has adequate emotional intelligence to handle a variety of situations professionally and in accordance with regulatory compliance
- Experience within a manufacturing, packaging and laboratory environments and associated equipment
Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is frequently required to stand, walk and sit and regularly required to talk or hear. The Employee must be able to traverse various areas of the facility including but not limited to the production, warehouse and QA departments. Employee is occasionally required to walk use hands to finger, handle or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. This role frequently operates a computer and/or other office machinery such as a calculator, copy machine, laptop, etc.
Environmental Conditions
The noise level in the work environment is usually moderate.
Acknowledgement
I have read the above statements and understand the intention is to describe the general nature and level of work performed by individuals assigned to this classification. It is not intended to be construed as an exhaustive list of all duties, responsibilities qualifications and skills. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requests for accommodations must be processed through and approved by Human Resources.
