QMS Investigator II
About The Position
This position investigates and writes out-of-specifications, deviations, corrective and preventive actions, change controls, and other related cGMP documents under moderate supervision. The QMS Investigator II supports moderately complex investigations and resolution of issues / potential problems related to Operations/Productions. The position writes and edits standard operating procedures (SOPs), change controls, and other related CGMP documents. In addition, the role may coordinate the review, approval and revision of procedures, documents, specifications, and forms. The Investigator will work with multiple departments and CGMP disciplines, such as Manufacturing operations, Quality Control, Microbiology, Facilities, and Quality Assurance.
Requirements
- High School diploma or equivalent required.
- 3-5 years of relevant experience in a CGMP environment, Manufacturing preferred.
- Has an established understanding of equipment, systems and technologies that enable issues to be translated to create accurate documentation.
- Must have a solution-based attitude.
- Strong listening and interpretive skills to successfully translate events into clearly written documents.
- Detail oriented with strong English writing skills.
- Strong verbal communication skills.
- Ability to work independently, within prescribed guidelines, or as a team member.
- Must be highly proficient with Microsoft Word and Excel.
Nice To Haves
- Bachelor's degree in Life Sciences or a related field preferred, or equivalent combination of education and/or relevant work experience will be considered.
- Previous experience with investigations is preferred.
- Previous experience writing technical documentation (deviations, corrective and preventative actions, SOPs, etc.) preferred.
- Emphasis on aseptic processing and compliance experience preferred.
- Aseptic gowning experience and mechanical aptitude are a plus.
Responsibilities
- Initiates and/or supports moderately complex investigations and resolution of issues / potential problems related to QMS and/or Operations/Production.
- Coordinates and supports interdisciplinary working teams with recommendations, advice, and action plans for moderately complex investigations, change controls, gap analyses, and risk assessments.
- Authors and revises change controls and other technical documentation.
- Manages specific components of moderately large-scale deviations.
- Tracks and trends documentation and data as specified.
- Maintains a GLP/CGMP environment and follows Standard Operating Procedures (SOPs).
- Adjusts responsibilities and activities to meet client and internal expectations.
- Follows up on open documents/records to ensure close out of investigations to enable product release in a timely manner.
- Provides support for internal, client, and regulatory audits as needed.
- 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.
Benefits
- paid time off
- health insurance coverage (including dental and vision)
- a flexible spending account
- a 401(k) plan
- eligibility for an annual performance bonus
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
