Compliance Associate II

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.

Perform moderately complex activities pertaining to assuring compliance with applicable regulatory requirements. Conduct internal audits; assist with customer audits, and track audit corrective actions.

Essential Duties and Responsibilities:

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

• Assists with internal audit program by conducting audits, writing audit reports, evaluating responses to audit observations, and verifying closure of corrective actions.

• Assists with vendor quality program by conducting paper audits and tracking vendor quality issues and changes.

• Assists with customer audit program by retrieving and preparing documentation, communicating and coordinating with internal SMEs, and tracking completion of corrective actions.

• Assists with regulatory inspection process by retrieving requested documentation and communicating with SMEs.

• Regular and reliable attendance on a full time basis [or in accordance with posted schedule].

• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.

• Embodies PCI Pharma's cultural values and aligns daily actions with department goals and company culture.

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 Life Sciences discipline or equivalent preferred.

• Minimum of two to four (2-4) years of experience in a GMP environment.

• Basic understanding of regulatory requirements related to aseptic drug product manufacturing and testing; Good understanding of internal requirements related to quality management systems, risk management, and supplier qualification; Developing communication and team collaboration skills

• Detail-oriented with strong organizational skills; Proficient with Microsoft Office applications

Physical 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties the employee is:

• constantly required to sit, and to reach to use computers and other office equipment

• constantly stand for extended periods of time, up to four (4) hours/time.

• frequently required to lift up to 40 pounds

• constantly required to view objects at close and distant ranges with hand and eye coordination

• frequently required to communicate with others

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

Work Environment:

Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Employee may occasionally be exposed to fumes, airborne particles, toxic chemicals, vibration, and bio-hazardous materials. The work environment is fast-paced and demanding. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required.

This job description may not list all activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or be assigned at any time with or without notice.

*The hiring rate for this position is $36.54 - $41.11 per hour plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

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Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

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.

At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.