QMS Investigator I
About The Position
Under direct supervision, the QMS Investigator I investigates, authors, coordinates, and revises deviations, corrective and preventative actions, complaints, and other cGMP documents, including Master Production Batch Records. The role supports straightforward investigations and resolution of Manufacturing issues or risks, works across departments, and may coordinate reviews, revisions, and approvals of procedures and related documentation. This position supports timely investigations and issue resolution related to Operations/Production, may contribute to cross-functional teams, and provides support for internal, client, and regulatory audits. The role is responsible for maintaining a GLP/CGMP environment, following SOPs, and completing documentation and records in a timely manner. This is an evergreen posting to build a pipeline of candidates for current and future opportunities.
Requirements
- High school diploma or equivalent required.
- 1–3 years of relevant experience in a CGMP environment; Manufacturing experience preferred.
- Detail-oriented, with strong English writing skills.
- Strong verbal communication skills.
- Ability to work independently within prescribed guidelines or as a team member.
- High proficiency with Microsoft Office applications.
Nice To Haves
- Bachelor's degree in Life Sciences or a related field, or an equivalent combination of education and/or relevant work experience.
- Manufacturing experience in a CGMP environment.
- Previous experience with investigations.
- Familiarity with relevant technical documentation, including deviations, corrective and preventative actions, and SOPs.
Responsibilities
- Under direct supervision, initiate and support timely investigations and resolution of issues related to Operations/Production; support cross-functional teams as needed.
- Author and revise deviations, complaints, and other technical documentation.
- Manage specific components of large-scale deviations.
- Track and trend relevant documentation and data as specified.
- Maintain a GLP/CGMP environment and follow SOPs.
- Adjust responsibilities and activities to meet client and internal expectations.
- Follow up on open documents and records to ensure timely closeout of batch record revisions and investigations.
- Provide support for internal, client, and regulatory audits as needed.
- Become familiar with new equipment, systems, and technologies to create and maintain accurate documentation.
- Maintain regular and reliable attendance on a full-time basis or in accordance with the posted schedule.
- Exhibit professional behavior with internal and external business associates consistent with company policies and practices.
- Align daily actions with PCI Pharma Services cultural values, department goals, and company culture.
- Support a safe and environmentally sustainable workplace by following PCI EHS policies and procedures.
- Perform other duties as assigned to support departmental and organizational objectives.
Benefits
- Paid time off
- Health insurance coverage, including dental and vision
- Flexible spending account
- 401(k) plan
- Eligibility for an annual performance bonus
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
