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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in quality oversight, inspection processes, and adherence to FDA regulations within a pharmaceutical environment. Proficient in label control, inventory management, and SAP transactions, with strong organizational and analytical skills.
Highest-signal resume keywords
Quality OversightFDA Regulations ComplianceLabel ControlSAP ProficiencyInventory Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Quality InspectionAQL SamplingLot ReconciliationPackaging OperationsDocumentationRetention Sample InspectionDistribution Release VerificationGMP KnowledgeAnalytical SkillsProblem-Solving
Soft Skills
Attention to DetailOrganizational SkillsInterpersonal SkillsCommunication SkillsProactive Attitude
Tools & Technologies
SAPMS Office
Industry Keywords
PharmaceuticalGMPFDA Regulated EnvironmentQuality ControlPackaging Process
About the role
Key responsibilities & impact- Responsible for quality oversight of the final container inspection and packaging operations
- For example, AQL (Acceptable Quality Limit) sampling and inspection of packaged final container product
- Packaging area release, quality verification of first print and last print samples
- Lot reconciliation, etc.
- Perform Label Control duties
- i.e. inventory count and issuance of labels and inserts for the packaging process
- Receive, store and inspect retention samples (includes intermediates and final container products)
- Inspect and release finished product produced in Instituto Grifols
- Perform annual inventory of quarantine areas and quarterly inventory of label control areas
- Perform distribution release verification of intermediates and final container products
- Perform packaging work order review
- Perform various SAP transactions from the processes mentioned above
- Strict adherence to procedures and practices according to FDA regulations
- Strong emphasis on documentation according to FDA regulations
- Adhere to departmental corporate safety policies
Requirements
What you’ll need- Associate degree in Biology, Chemistry, Chemical Engineering or closely related scientific discipline is required
- Bachelor's degree preferred
- Related experience in a pharmaceutical, GMP, or FDA regulated environment is preferred
- Requires a basic understanding of quality inspection and label control
- Strong organizational, analytical, and problem-solving skills with the ability to make structured decisions on a routine basis
- Must be proactive, results oriented, and have strong attention to detail
- Self-starter with strong work ethic and the ability to exercise good judgment
- Ability to effectively prioritize and manage multiple tasks to meet targeted deadlines
- Strong interpersonal skills with the ability to interact with personnel at all levels in a team environment
- Excellent verbal and written communication skills in the English language
- Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
- Specific experience with SAP is preferred
- Must be flexible with working hours / shifts in order to accommodate the 24 hour, 7 day plant operation.
Benefits
Comp & perks- Medical
- Dental
- Vision
- PTO
- up to 5% 401(K) match
- tuition reimbursement