QA Specialist

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 offices North America.

We are currently looking for a Full-Time QA Specialist to join our team in our Plainville, CT site. The successful candidate will join a team dedicated to the production of the ALK skin test antigen for penicillin allergy.

The primary responsibilities for this position include:

• Support quality documentation including development, revision, and obsolescence of procedures and material specification, COA & COC for final product.
• Review of executed batch records and QA support of QC and Operations groups to achieve timely product release.
• Executing, supporting and leading compliance projects as needed.
• Support and assist in quality (internal and external) audits, supplier quality agreements and suppliers monitoring and performance.
• Quality Management of computerized systems in the Pharmaceutical Industry and the ability to interpret 21 CFR part 211 and 11 in relation to computerized systems.
• Handle, review or approve Stability reports, Quality incidences including, but not limited to, investigations, OOTs, OOSs and deviations 
• Ensure implementation and effectiveness of quality systems across all operational areas
• Support operational processes, analytical methods, equipment, etc., ensuring that they are designed and validated according to relevant GMP requirements (FDA, ICH, Health Canada)
• Participate in customer and consumer complaint investigations and resolution.
• Support handling, preparation and presentation of periodic reports such as Management Review, annual product reviews and quality KPIs.
• Support in training requirements at the site ensuring staff training records are compliant with GMPs and local and corporate procedures.
• Training and qualification as a visual inspector for AQL inspections.
• Train and qualify for work in the ISO 5/6 cleanroom environment.
• Communicate clearly internally and externally. 
• Other assignments and tasks as directed by QA Management.

Experience:

• BS degree in Biology, Biochemistry, Chemistry or related technical / physical science preferred
• Minimum 5 years' pharmaceutical regulated industry experience within Quality Assurance and compliance, manufacturing quality and/or regulatory affairs
• 2+ years in direct or indirect leadership in a group setting and within a GMP environment
• Working knowledge of CGMP practice (21 CFR Parts 210, 211). 

Skills and competences (interpersonal, language, communication etc.)

• Can work independently and lead a task group when needed to assure that products, processes, systems, and procedures are in compliance with relevant regulatory authority requirements and global ALK procedures.
• Able to work with systems such as SAP, Document Control Systems QADOCs, etc.
• Strong interpersonal skills.
• Good cross functional collaboration skills.
• Result focused.
• Able to solve complex situations and problems, technical and people related.
• Able to handle conflicts and drive for mutually agreed to decisions based on relevant information.
• Culture awareness and understanding the way of behaviour in different cultures.
• Fluent in English

Note: The ALK Plainville CT facility processes penicillin. Those with confirmed allergy to penicillin should reevaluate their interest in this role.

Approximate annual salary range: $65,000 to $85,000. The salary range is an estimate in good faith for the position. Final compensation can vary based on the candidate's experience, skills, and knowledge.

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
• 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.