QMS Investigator I

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.

Under direct supervision, this position may investigate, author, coordinate, and revise deviations, corrective and preventative actions, complaints, and other cGMP documents such as Master Production Batch Records. The QMS Investigator I supports simple write-ups and the resolution of issues or risks related to Manufacturing. This role works with multiple departments, and may coordinate the review, revision, and approval of procedures and associated documentation.

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.

• Under direct supervision, initiates and supports the timely completion of investigations and resolution of issues related to Operations/Production. May support cross-functional teams.
• Authors and revises deviations, complaints, and other technical documentation.
• Manages specific components of large-scale deviations.
• Tracks and trends relevant documentation and data as specified.
• Maintains a GLP/CGMP environment and follows SOPs.
• Adjusts responsibilities and activities to meet client and internal expectations.
• Follows up on open documents/records to ensure timely close out of batch record revisions and investigations.
• Provides support for internal, client, and regulatory audits as needed.
• Becomes familiar with new equipment, systems, and technologies to create and maintain accurate documentation.
• 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 Services cultural values and aligns daily actions with department goals and company culture.
• Foster a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures
• Performs other duties as assigned to support departmental and organizational objectives.

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 of performing the duties listed below with or without reasonable accommodation which may be made to enable individuals with disabilities to perform the essential functions.

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
• occasionally stand for extended periods of time, up to four (4) hours/time.
• occasionally required to lift up to 10 pounds
• frequently required to view objects at close and distant ranges with hand and eye coordination
• constantly 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 workday, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

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

• High School diploma or equivalent required. Bachelor's degree in Life Sciences or a related field preferred, or equivalent combination of education and/or relevant work experience will be considered.
• 1-3 years of relevant experience in a CGMP environment, Manufacturing preferred.
• Previous experience with investigations preferred.
• Familiarity with relevant technical documentation (deviations, corrective and preventative actions, SOPs, etc.) preferred.
• Detail-oriented with strong English writing skills.
• Strong verbal communication skills.
• Ability to work independently, within prescribed guidelines, or as a team member.
• Highly proficient with Microsoft Office applications.

Please Note: This is an evergreen posting intended to build a pipeline of qualified candidates for current and future opportunities. Candidates may be contacted as business needs arise.

*The hiring rate for this position is $21.69 - $24.41 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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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.