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Position Title: Quality Operations Supervisor

Location: Philadelphia, PA

Department: Quality (Operations)

Shift: 3rd shift

Reporting To: Vaughn Ricchini

Responsible For (Staff): Yes

Summary of Objective:

This position is responsible for providing the direction, organization, alignment, and monitoring cGMP compliance to ensure the successful, cost effective, timely and safe processing of customer orders. The position leads and oversees the daily quality activities throughout operations in all of pre, post and in-process functions. You as a working Supervisor would perform audits, production room documentation, sampling requirements, reviews equipment challenges, audits material management and that hourly in-process inspections have been performed within compliance. The Quality Operations Supervisor is essential in driving improvements into our Right First Time (RFT) metrics. They are also responsible for leading and realizing continuous quality and process improvements on the production floor by mentoring, coaching and training their operational counterparts and underlings.

Essential Duties and Responsibilities:

Coach, mentor and train the Quality Auditors and/or Quality Coordinators in order to develop them from a Quality and cGMP perspective.

Assess risks in accordance with the guidance delineated in ICH Q9, ISO, 21CFR, and EU guidelines and develop robust and sustainable solutions.

Schedule and manage workload of Quality Auditor and/or Quality Coordinators.

Performs quality auditing functions within operations in the form of pre-flight, first piece, material management and in-process inspections on an internal level.

Track, management and trend focus areas within operations and escalates findings to counterparts for immediate disposition.

Oversee the timely issuance and review of batch records in order to meet production schedules and product release commitments to customers.

May prepare and distribute required documentation for requested production work orders.

May perform record reviews of completed orders to ensure compliance with cGMP's and customer requirements.

May perform record creation of in-process orders ensuring compliance with cGMP's and customer requirements.

May review and interpret customer standards, procedures, and specifications for dissemination relative to batch records, forms and material specifications.

May organize internal and customer approval of batch records and specs.

Identify, track, and communicate non-conformances and documentation compliance with other departments for clarity.

Provides quality oversight to non-conformances by assessing risk, product impact and implementing effective CAPA's in the eQMS system.

Prepares planned deviations requested when needed.

May perform label creation in the form of shipper labels, pallet labels and tray labels when needed.

May perform label approvals when needed.

Provide guidance and support of the Quality Auditors and the Operations staff whenever challenges and/or inspections do not pass; ensure that impacted material is appropriately quarantined during these events and management notified.

Observe and correct all quality deficiencies in operations or in individual packaging suite.

Highlight quality and operational improvements in order to foster an environment of proactive and continuous process improvement.

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 quality team and individual goals and objectives in alignment with Customer Focused Team goals and customer requirements.

Ensure strong alignment and coordination with Customer Focused Teams and functional groups.

Investigates, analyzes and reports key quality metrics as it relates to the Quality Auditors and/or Quality Coordinators.

Offers flexibility across shifts.

Able to make decisions for the site related to Quality matters or events.

Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

Attendance to work is an essential function of this position.

Perform other duties as assigned by Manager/Director of Quality Operations.

Shift is Monday-Friday from 12:00am-8:30am

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: From 1/2 to 3/4 of the day.
• Install, place, adjust, apply, measure, use, or signal: None.
• Ascend/Descend or Work Atop: Up to 1/4 of the day.
• Position self (to) or Move (about or to): From 1/2 to 3/4 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.
• On an average day, the individual can expect to move and/or transport up to 10 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

WorkEnvironment:

The following are someenvironmental conditions that one may be exposed to on a daily basis and for various lengths of time:

• Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear For 1/4 to 1/2 of the day.
• Work is primarily performed at a desk and/or in an office environment. For up to 1/4 of the day.
• Work near moving mechanical parts For 1/4 to 1/2 of the day.
• Extreme cold (non-weather) For up to 1/4 of the day.

Qualifications:

Required:

• Bachelor's degree in applicable field of study preferred, or equivalent combination of education and experience.
• Functional Mathematical Skills.
• Advance Computer Skills: Must be able 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.
• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

Preferred:

• Current or previous experience working in a pharmaceutical packaging environment.
• 1-2 years' experience in people managing.
• 1-2 years deviation management utilizing an eQMS system.
• Ability to follow instructions and respond to management direction.
• Ability to work independently and/or part of a team.
• Ability to display excellent time management skills.

Join us and be part of building the bridge between life changing therapies and patients.

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.