What are the responsibilities and job description for the QA Specialist position at ALK-Abello, Inc?
About ALK
ALK is a forward-thinking allergy company with a long tradition of allergy innovation. ALK is devoted to improving quality of life for people with allergies by developing pharmaceutical products that target the actual cause of allergy. ALK is the world leader in allergy vaccination (immunotherapy) – a unique treatment that induces a protective immune response which reduces and potentially halts the allergic reaction.
Since 1923, we have been working to improve the quality of life for allergy patients by developing products that target the cause of allergy. With over 2,200 employees, and with subsidiaries, production facilities and distributors worldwide, we are in a unique position to further the advancement of allergy treatments. The company is publicly traded on NASDAQ OMX Copenhagen (OMX: ALKB) with global headquarters in Horsholm, Denmark and US Offices in Round Rock, TX, Bedminster, NJ, Port Washington, NY, Post Falls, Idaho, Luther, OK, Oklahoma City, OK and Mississauga, Canada.
We are currently looking for a Full-time Sr. Specialist, QA to join our team in our Port Washington, NY facility. The QA Senior Specialist will be working alongside the Quality Assurance team and Production team. The ideal candidate will be comfortable working in a fast-paced environment, can manage multiple site-specific projects at one time and feel comfortable taking the lead when necessary.
Primary Responsibilities:
The primary responsibilities for this position include:
- Perform and review deviation investigations and ensure that proper corrective and preventive actions are implemented
- Ability to lead or execute compliance projects for Americas sites as needed
- Ability to review batch records and incoming material release and perform other QA responsibilities relevant to daily operations.
- Quality Management of computerized systems in the Pharmaceutical Industry
- Able to interpret 21 CFR part 211 and 11 in relation to computerized systems
- Identification of electronic records and signatures in computerized systems
- Mapping of process data flows to establish archiving of data and retention periods.
- Change Management of Computerized Systems to set the effort of validation for the identified change
- Experience in GXP evaluation of the Computerized systems to ensure adherence to the FDA regulations and data integrity requirements
- Create and execute a risk assessment for computerized systems
- Create Standard Operating Procedures, Work Instructions, and other documents as necessary for establishing and maintaining an IT audit program to ensure system(s) compliance
- Schedule, Perform and Report on audits of ALK systems as needed
- Systematically track audits and CAPAs for effectiveness
- Support Quality Assurance Operations and other personnel in efforts to assure regulatory compliance
- Assist during inspections by Regulatory Authorities
- Other duties as assigned
Skills and Experience:
Competences required to fulfil the area of responsibilities and work assignments:
- Bachelor's degree in Science, Information Technology or equivalent experience related to IT System Development, Implementation and/or Validation preferred.
- 2 – 5 years of related experience in operation or with IT systems in a regulated industry
- Working knowledge of CFR Parts 11 & 211
- Work experience with LIMS preferred
- Knowledge of SAP & ICH Q10 a plus
- CQA or CISA preferred
- Ability to Travel Required
Why ALK?
At ALK, we believe in providing an environment and culture in which our people can thrive, develop, and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance.
ALK offers:
- Excellent benefits including medical, dental, and vision
- Life and Disability insurance covered at 100%
- 401(k) plan with generous employer contribution
- 13 company-paid holidays per year
ALK is an Equal Employment Opportunity / Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Salary : $61,400 - $77,800