Experience Inc. Jobs

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Job Title:

QA Specialist II - Compliance

Department/Group:

Select a Department.

Location:

Choose a Location.

Reports to:

QADir., Quality Systems & Compliance

FLSA Status:

Exempt

Prepared By:

Michelle Herrick

Date:

9/12/2023

Approved By:

Click here to enter text.

Date:

Click here to enter a date.

Summary of Objective:

This position is responsible for maintaining and adhering to PCI Pharma Services and regulatory compliance requirements for established quality system programs by performing internal audits, hosting client audits and providing assistance during regulatory agency inspections.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Responsible for scheduling and hosting client audits and coordinating audit responses for any deficiencies from internal stakeholders. Responsible for follow up and tracking of client audit observation commitments to assure timely closure. Responsible for performing internal and audits to evaluate compliance to standard operating procedures, quality and regulatory standards and is responsible for creating and issuance of audit reports and coordinating audit responses for any deficiencies from internal stakeholders. Responsible for follow up and tracking of internal audit observations commitments to assure timely closure Responsible for reviewing and approving all audit responses to assure non-recurrence of deficiencies Maintain, trend, analyze and report quality metrics as it relates to internal and client audits Provide support and metrics for Quality Council meetings Provides support during FDA and other regulatory agency inspections Writes and revises QA Standard Operating Procedures (SOP) Support continuous improvement initiatives May be assigned to assist with supplier audits as needed. Less than 10% travel. 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: 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. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

• Stationary Position: From 1/2 to 3/4 of the day.

• Move, Traverse: Up to 1/4 of the day.

• Operate, activate, use, prepare, inspect, or place: None

• Install, place, adjust, apply, measure, use, or signal: None.

• 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: From 1/2 to 3/4 of the day.

On an average day, the individual can expect to move and/or transport up to 10 pounds

choose an item.

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: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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

• Work is primarily performed at a desk and/or in an office environment. for 1/2 to 3/4 of the day.

• Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for up to 1/4 of the day.

• Choose an item. for Choose an item.

• Choose an item. for Choose an item.

• Choose an item. for Choose an item.

• Choose an item. for Choose an item.

• Choose an item. for Choose an item.

The noise level in the work environment is typically, choose an item.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Bachelor's Degree in a related field and/or 5-10 years related experience and/or training.

• College Level 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:

• Ability to effectively present information to various people as the job requires.

• Ability to follow instructions and respond to management direction.

• Ability to work independently and/or as part of a team.

• Ability to display excellent time management skills.

• Ability to work in a dynamic, faced paced work environment.

Ability to communicate clearly and concisely with cross functional staff, members of management and external clients.

#LI-KH1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

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.

Why work for PCI Pharma Services?

At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled