Pharmaceutical QA/QC Senior Specialist (2nd Shift)
Pharmaceutical QA/QC Senior Specialist (2nd Shift)
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Job Description
This position provides Quality Assurance oversight for Quality Control (QC). Provide QA (Quality Assurance) review and approval of Quality method validation/ QC equipment qualification QC protocol reports QC process control document new and existing procedures and Quality Control deviation/investigations. Supports process improvements implementation. This role is in Sanford NC.
POSITION RESPONSIBILITIES:
- Perform QA technical review for assigned areas such as Validation documents Method transfer Protocol amongst others.
- Provide final QA approval on simple change control effectiveness check CAPA implementations compendial assessments and other documents associated with the business unit.
- May also review and approve documents such as Deviation complaints investigations Laboratory investigations (OOS/OOT/OOE) and other Quality Events/Lab Events Electronic build of Master Batch or any electronic record when needed and all associated to compendial changes.
- Capable to make quality decisions in real time according to regulations and procedures.
- Ability to work collaboratively with internal partners to resolve technical issues.
- Willing to perform other duties as assigned and take ownership to support the implementation of activities needed for the startup.
Qualifications :
- Bachelors or Masters Degree in relatable field (Microbiology Chemistry Pharmaceuticals etc.)
- Bachelors degree and 68 years of experience
- Masters degree and 46 years of experience
- Relevant experience includes:
- Experience in a Microbiologyfocused Quality Control Laboratory and cGMP Laboratory environment.
- Familiarization with Pharmacopeia requirements. (e.g. USP JP EMEA amongst others.
- Familiarization with the Data Integrity requirements.
- Deviations Change Controls Stability Protocols and all the implementation activities. Support in CAPA closures Effectiveness checks and experience in Root Cause Analysis tools.
- Experience in a quality assurance role preferably in Quality Assurance for a Quality Control role in the document such as: (e.g. OOS (Out of Specification) OOE (Out of Expectation) OOT (Out of Trend) investigation specification method transfer protocol stability protocol and others).
- Relevant experience includes:
- Proven ability to work in a team environment through conflict resolution and negotiation.
- Valid drivers license and personal transportation
- Authorization to work in the United States indefinitely without restriction
Additional Information :
Position is fulltime MondayFriday 2pm10pm Candidates currently living in a commutable distance to Sanford NC are encouraged to apply.
Excellent full time benefits including comprehensive medical coverage dental and vision options
Life and disability insurance
401(k) with company match
- Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
