What are the responsibilities and job description for the Quality Assurance Specialist I position at SPI Pharma?
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 QA 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 good manufacturing practices and SPI Pharma standard operating procedures.
Essential Duties and Responsibilities
- Generate, review and approve Batch Records, logbooks and labels
- Perform reviews of batch records, production in-process (PIP) test sheets, logbooks and campaign check lists in a timely fashion
- Disposition raw materials, packaging materials and finished products
- Generate Certificates of Analysis (CoAs) and Certificates of Testing (CoTs) as needed
- Provide a quality presence in the production area and provide cGMP guidance when needed
- Perform lot management transactions in Adage as needed
- Create pack orders and perform inventory moves in ASSISTics warehouse management software as needed
- Perform quarterly GMP internal audits and assist in customer audits as needed
- Document metrics for Annual Product Reviews (APRs) and Batch Record error rates
- Conduct suite and equipment cleaning inspections and approve/release once acceptable
- File and maintain controlled documents appropriately after completion.
- Generate and manage Supplier Quality Investigation Reports (SQIRs).
- Assist with customer complaint investigations as needed.
- Generate change control documents as needed.
- Perform deviation investigations when needed.
- Perform other duties, as assigned.
Education, Skills and Experience
- High school diploma with 1-3 years of relevant Quality Assurance work experience in a pharmaceutical or similar industry.
- Proficient in Microsoft Office software and familiar with Adage ERP software, BlazeLIMS Data System software and ASSISTics warehouse management or similar software.
- Attention to detail.
- Excellent verbal and written communication skills.
- Ability to work independently and in a group on a variety of projects.
- Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively.
- Strong problem-solving techniques and ability to make sound decisions.
Job Type: Full-time
Pay: $23.00 - $28.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Tuition reimbursement
- Vision insurance
Schedule:
- 8 hour shift
- Night shift
Shift availability:
- Night Shift (Required)
Ability to Commute:
- Grand Haven, MI 49417 (Required)
Ability to Relocate:
- Grand Haven, MI 49417: Relocate before starting work (Required)
Work Location: In person
Salary : $20