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Company Name : SPI Pharma
Company Location : 40 Cape Henlopen Dr, Lewes, DE 19958
Job Position : Quality Assurance Specialist I
Job Category : Jobs in Delaware
Job Description :
Want to start a new career in the exciting field of pharmaceuticals? Are you safety and quality vigilant? Launch a new career with growth opportunities!
SPI Pharma is for you!
SPI Pharma is looking for a QC Specialist to join their team!
Benefits day 1!
401k match of 1:1 for the first 5% contributed plus an additional 5%
Join the small team that is making a big difference!
Who is SPI Pharma?
We are a globally recognized market leader in Pharmaceutical Excipients and Drug Delivery Systems supplying products and formulary solutions to some of the world’s largest pharmaceutical manufacturers.
SPI Pharma is part of Associated British Foods – a diversified international food, ingredients and retail group with annual sales of $20B, 137,000 employees and operations in 50 countries across Europe, southern Africa, the Americas, Asia and Australia.
What would I be doing?
As a team member of the Quality group, you would help to ensure that the site follows all Federal, State and company mandated quality compliance programs with emphasis on proper GMP documentation and GMP auditing.
Essential Duties and Responsibilities
- Ensure site awareness of quality standard operating procedures (SOPs) and (cGMP) regulations
- Liasion with production as a representative for the quality program with specail emphisis on proper GMP documentation and auditing
- Complete quarterly GMP audits and assist with Quality System audits as directing
- Provide a Quality presence in the production area while being the liaison with production employes for GMP compliance
- Review and approve batch records and labels after generation
- Review in-process batch records and production test pages, logbooks and housekeeping practices
- Disposition of finished products, raw materials and packaging materials
- Final review of campaign checklists, logbooks, test data and batch records, along with maintaining batch record metrics
- Conduct room and equipment inspections and approve release after production cleaning
- Cover and tag clean equipment as needed
- Properly maintain and file controlled documents
- Generate and manage Supplier Quality Investigation Reports (SQIR).
- Able to identify basic technical problems and develop solution ideas with help of supervision
- Ability to perform problem investigations with little to no supervision.
Education, Skills and Experience
- Bachelor’s degree in Science field required and/or 1-3 years of relevant and equivalent work experience work experience within the pharmaceutical or chemistry industry OR High school diploma or G.E.D with 2 years quality experience within the pharmaceutical or chemical industry or equivalent combination of education, training and experience.
- Experience with typical Quality projects such as current Good Manufacturing Practice (cGMP) documentation review/approval, auditing, product and raw material release, change control, investigations, and training
- Ability to plan and manage multiple priorities / projects
- Ability to work with all personnel in a tactful manner
- Attention to detail
- Problem analysis and problem resolution skills
- Excellent interpersonal and communication skills
- Strong team player.
- Ability to act independently when handling recurring issues
- Ability to learn and adapt quickly to new situations and/or priorities
- Meet project deadlines
- Displays initiative and technical commitment.
Job Type: Full-time
Pay: From $50,000.00 per year
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
- 8 hour shift
- Day shift
- Monday to Friday
Supplemental pay types:
- Bonus pay
Ability to commute/relocate:
- Lewes, DE 19958: Reliably commute or planning to relocate before starting work (Required)
Work Location: One location
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