Incoming Quality Assurance (IQA) Supervisor - PCI Pharma Services

Position Title: Incoming Quality Assurance (IQA) Supervisor
Location: Philadelphia, PA - Red Lion Rd.
Department: QC Inspection
Shift: 1st
Reporting To: Quality Engineer Incoming Manager
Responsible For (Staff): yes
The Incoming Quality Assurance (IQA) Supervisor is responsible for aligning the members of the IQA team with the approved quality standards for incoming materials received from suppliers to ensure compliance with company drawings, specifications, and requirements. Select, supervise, empower, coach, develop and retain a team of qualified IQA Inspectors while partnering with functional teams from the Business Units and Procurement. The position functions as a working supervisor so aspects of the IQA Inspector role apply. The verification of incoming material includes, but is not limited to: current revision, total quantity, material type, physical dimensions, aesthetic appearance, etc. and will involve the use of inspection equipment such as calipers, micrometers, scales, balances, go/no-go gauges, etc. The position will also be responsible for interacting with the engineering and production personnel to determine the cause and disposition of non-conforming material.
Direct supervision of 5-10 IQA inspectors. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; staffing, planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
ESSENTIAL DUTIES AND RESPONSIBILITIES:

* Select, supervise, empower, coach, develop and retain a team of qualified individuals through effective employee development, performance management, succession planning and recognition.
* Ensure the appropriate team structure is in place by performing workload analysis to manage headcount and to ensure we deliver on customer and business commitments.
* Establish team and individual goals and objectives in alignment with department and site objectives.
* Manage the training and development of the team including onboarding of new employees
* Provide support for customer audits, visits and conference calls.
* Ability to foster an environment of continuous process improvement
* Attendance and the ability to inspire and lead a team are essential aspects of this job
* Develop and complete any relevant CAPA actions associated with the IQA area
* Ability to understand and execute all aspects of the activities performed in Incoming Quality Assurance (IQA) related to the inspection, control, disposition, and release of incoming material.
* Maintaining inspection records and procedures in compliance with the company's Quality Management System and any applicable federal, state, or regulatory requirements.
* Record inspection results and take action on material disposition in accordance with approved company processes and procedures.
* Accurately process all material transactions and ensure accuracy throughout the inspection process.
* Create detailed documentation (pictures, PowerPoint presentations, etc.) of non-conforming material in order to effectively communicate the issue to the appropriate supplier.
* Must be an effective team player who actively participates and cooperates with others to improve the overall quality of our processes.
* Represents Quality on assigned project teams and leads those projects relevant to Quality to conclusion.
* Proactively follows up internally and with customers to secure missing documentation (i.e. Certificate of conformance, Certificate of Analysis, etc.) in order to ensure that all Quality expectations and parameters have been met and to expedite release of the material.
* Supports company strategic, departmental operational excellence and manufacturing regulatory initiatives. Responsible for acting as the quality representative on capital projects.
* Actively participates in site inspection/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information and presenting to inspectors on required topics.
* Provides training to new incoming personnel and ensures compliance with departmental procedures.
* Interacting with customers in order to answer Quality related questions in a professional and courteous manner.
* This position may require overtime and/or weekend work.
* Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
* Attendance to work is an essential function of this position
* Performs other duties as assigned by Manager/Supervisor.

Special Demands:

* Stationary Position: Under a 1/4 of the day.
* Move, Traverse: 3/4 of the day and up.
* Operate, activate, use, prepare, inspect, or place: 3/4 of the day and up.
* Install, place, adjust, apply, measure, use, or signal: 3/4 of the day and up.
* Ascend/Descend or Work Atop: None.
* Position self (to) or Move (about or to): From 1/4 to 1/2 of the day.
* Communicate or exchange information: 3/4 of the day and up.
* Detect, distinguish, or determine: 3/4 of the day and up.
* Ability to sit or stand for long periods of time. Ability to move safely in a shipping/receiving environment.
* Must be able to lift up to 25 lbs.
* 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. Must be physically capable to perform the above duties with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.
On an average day, the individual can expect to move and/or transport up to 25 pounds
less than 1/4 of the day.
This position may have the following special vision requirements.
☒ Close Vision ☐ Distance Vision ☒ Color Vision ☐ Peripheral Vision ☒ Depth Perception
☒ Ability to focus ☐ No Special Vision Requirements
Work Environment:

* Work is primarily performed at a desk and/or in an office environment. for 1/4 to 1/2 of the day.
* The noise level in the work environment is typically, moderate.
QUALIFICATIONS:
Required:

* Bachelor's Degree in a related field and/or 5-10 years related experience and/or training.
* Possesses excellent organizational, time management and multi-tasking skills in order to meet commitments and deadlines.
* Knowledge of basic test instrumentations such as scales, balances, micrometers, calipers, rulers, etc.
* Strong problem-solving skills and detailed oriented.
* Must have excellent computer skills including Microsoft Word, Excel, PowerPoint, Outlook, and Project, and a working knowledge of GMPs.
* Basic understanding of cGMP requirements and AQL sampling plans
* Legible Handwriting
* Any Lean Six Sigma or process improvement training is a plus
* Basic Mathematical Skills
* Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
* Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
* High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
* High Standard of Report Writing
Preferred

* High school education and at least 5 years of pharmaceutical, scientific, or pharmaceutical packaging experience. Experience must include an inspection, laboratory, or product release background.
* Ability to work independently and/or as part of a team.
* Ability to display a willingness to make decisions.
* Ability to follow instructions and respond to management direction.
* Ability to display excellent time management skills.

Equal Opportunity Employer/Vet/Disabled