Easter Seals Jobs

This position will manage the Quality Systems group within the Quality department. Quality Systems includes elements including but not limited to unplanned deviations, non-conformance reports, corrective and preventive actions, change controls, temporary change controls and document change controls, product complaints, document control, training, SOPs, etc.

The Quality Systems Manager will be responsible for continuous improvement of the Quality Systems in response to business needs, customer audits and regulatory inspections, and overall oversight of the systems.

1. Job Tasks

• 1.1 Manage the Quality Systems group to ensure that systems and processes are operating in a state of control and in compliance with regulatory requirements and internal SOPs.
• 1.2 Support and drive the ongoing implementation of an electronic Quality Management System.
• 1.3 Manage the document control function, including issuance and archival of GMP documentation, issuance of production batch records.
• 1.4 Review and approve all deviations, investigation reports, non-conformance reports and corrective and preventive actions; ensure documents are closed in a timely manner.
• 1.5 Manage the CAPA system, ensuring appropriate corrective and preventive actions are identified and implemented as required.
• 1.6 Manage the SOP system to ensure that procedures are current and reflect the intended process.
• 1.7 Track and investigate product complaints; ensure appropriate investigation and closure though final response to customers.
• 1.8 Administer the Change Control program to ensure all changes are appropriately assessed, documented, implemented and closed on time.
• 1.9 Manage the training program; support the development of individual training plans, track training completion.
• 1.10 Develop and track key Quality metrics and KPIs to monitor the performance of the Quality System; perform trend analysis.
• 1.11 Work overtime as needed to maintain job Assist the Site Head of Quality with all customer, third-party and regulatory audits, including preparation of responses to audit and inspectional observations.

2. Personal Attributes

• 2.1 Energetic.
• 2.2 Self-starter.
• 2.3 Innovative.
• 2.4 Able to handle pressure.
• 2.5 Congenial.
• 2.6 Excellent communication skills.
• 2.7 Detail oriented.
• 2.8 Ability to work with others.

3. Physical Requirements

• 3.1 Majority of the job will be sedentary work, however, occasional periods of light work and infrequent periods of heavier work will be required occasionally.
• 3.2 The worker will be exposed to inside office, manufacturing, and warehousing environments.
• 3.3 Occasional travel may be required.
• 3.4 Employee will occasionally be exposed to odors, dust, and fumes.
• 3.5 Physical activities associated with this position include, but are not necessarily limited to, climbing, balancing, stooping, kneeling, crouching, reaching, standing, walking, pushing, pulling, lifting, fingering, grasping, feeling, talking, sitting, visual acuity and hearing.
• 3.6 Oral and written communication, employee must be able to receive, understand, and communicate verbal and written instruction and communicate in the English language.

4. Education/Experience

• 4.1 Minimum of 8-10 years of experience in a pharmaceutical and/or medical device environment.
• 4.2 Specific experience in the management of Quality Systems is required.
• 4.3 Bachelors degree in a scientific discipline.
• 4.4 Strong knowledge of 21 CFR 210 and 211, FDA Guidance and ICH Guidelines.
• 4.5 Organized, strong attention to detail, excellent written and verbal communication skills.
• 4.6 Demonstrated ability to work effectively in a collaborative team environment