Quality Compliance Analyst

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

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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:

Quality Compliance Analyst

Department/Group:

QC Direct

Location:

Philadelphia

Reports to:

Catherine Cabrera

FLSA Status:

Non-Exempt

Summary of Objective:

The Quality Analyst has the primary function to ensure compliance with regulatory requirements, with respect to the FDA, DEA, MHRA, EEU, and other regulatory agencies. The individual will also support regulatory submissions, inspections, and customer filing documentation requests. Participating and Host customer and regulatory inspections is also a requirement for this role.

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.

Work directly with customers and global regulatory agencies related to regulatory submissions and customer filings Complete customer questionnaires related to the facility and systems Participate, Host regulatory and customer audits Participate during internal audits Coordinate audit responses Coordinates Regulatory Agency audits with customers and internal staff Compiling and presenting metrics in relation to their job performance and performance of the area of responsibility Write and implement procedures according to the current regulations Generating, reviewing and maintain internal and DEA documentation related to receipts, shipments and inventory Submission of information/reports to the DEA (i.e. Quarterly Reports, Annual Reports, Quota Requests) This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance at 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: From 1/2 to 3/4 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): None.

• Communicate or exchange information: From 1/2 to 3/4 of the day.

• 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

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: 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 1/2 to 3/4 of the day.

The noise level in the work environment is typically, moderate.

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 1-5 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 work independently and/or part of a team.

• Ability to identify and resolve problems in a timely manner.

• Ability to demonstrate attention to detail.

• Ability to display excellent time management skills.

• Ability to interact with other departments.

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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.