SDO_Quality Assurance Specialist

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.

Summary of Objective:

The Quality Assurance Specialist (Document Control/Training) supports PCI’s packaging, labeling, and distribution operations by ensuring compliance with applicable cGMP regulations, internal procedures, and quality system requirements. This full-time position reports to the Quality Manager and is responsible for executing and supporting Quality Systems activities including document control, training administration, product and material release, production monitoring, investigations, CAPAs, audit support, inspection readiness, quality metric tracking, and continuous improvement initiatives

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.

1.   Independently perform product lot disposition by reviewing executed packaging records for completeness, accuracy, and compliance with cGMP requirements and company procedures with minimal supervision.

2.    Own and execute document control activities within the electronic Quality Management System (eQMS), including document issuance, revision, approval workflows, reconciliation, archival, and retirement activities, ensuring compliance with GDP and document control procedures.

3.    Coordinate, administer, and maintain the site training program, including assignment, tracking, and monitoring of GMP training curricula and periodic training requirements.

4.   Oversee onboarding and training activities for new hires, ensuring timely completion of required GMP and On-the-Job Training (OJT) requirements.

5.  Deliver and facilitate GMP and procedural training sessions as required to support employee competency and compliance.

6. Monitor training compliance metrics and proactively follow up on overdue training assignments to maintain inspection readinesss.

7. Collect, analyze, trend, and report document control and training quality metrics to support continuous improvement initiatives and management review activities.

8.  Maintain inspection readiness for training and document control systems, including timely retrieval of controlled documents and training records during audits and regulatory inspections.

9.   Lead or support continuous improvement initiatives to enhance quality system effectiveness, compliance, and operational efficiency.

Support and participate in internal audits, supplier audits, customer audits, and regulatory inspections, including audit preparation, response coordination, and follow-up activities.

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:

• University/college education in the fields of math, or science, or relevant practical experience
• Math Skills Required.
• Knowledge and experience with manufacturing processes and products                    
• Exceptional attention to detail and proofing ability
• Sound judgement when approving or rejecting work in keeping with specifications and internal quality control standards
• Effective interpersonal skills and the ability to influence and negotiate in the presentation of feedback to colleagues and superiors
• Computer knowledge to use software programs such as Access, Word, Excel, Internet, and custom company software, (ERP)
• Excellent organizational, and time management skills to ensure deadlines are met

Preferred:

• Knowledge of GMP and pharmaceutical standards is an asset
• Ability to demonstrate attention to detail.
• Ability to effectively present information to various people as the job requires.
• Ability to hold oneself in a professional manner.
• Ability to multitask.

The hiring rate for this position is $70,304-75,928 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.