Shire Quality Associate II - 2nd Shift in Round Lake, Illinois

SUMMARY:

Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities; identifies and assesses regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Shire quality practices

Essential Duties and Responsibilities:

  • THIS IS A 2ND SHIFT POSITION: 3:00pm-11:30pm, Monday through Friday

  • Leads ongoing, daily departmental operations

  • Leads assigned teams in achieving defined quality goals in an efficient, accurate and timely manner

  • Performs in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude; assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques; determines the logic, adequacy and effectiveness of processes, systems and related requirements; develops plans to correct identified risks including areas of non-conformance; informs management and implements approved corrective action plans

  • Writes, reviews, analyzes and revises written Standard Operating Procedures (SOPs) and submits procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.

  • Supports external assessments or audits

  • Assists with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.

  • Serves as Subject Matter Expert (SME) and provides training to local employees as needed on relevant area(s)

  • Performs and manages the raw material release process from receipt through release for manufacturing use

  • Embodies the Shire Leadership Behaviors: Be Positive. Be Accountable. Be Results-Driven. Be an Excellent Manager of Self and Others.

  • Other duties, tasks or projects as assigned

Qualifications:

  • Must be willing and able to work 2nd shift after completing training on 1st shift

  • Strong interpersonal skills and great attention to detail are necessary

  • Must be a strong team player with good problem solving skills

  • Good oral and written communication skills are critical

  • Demonstrated ability to lead people without authority, encourage teamwork and drive decision

  • Demonstrated ability to handle multiple projects concurrently

  • Well-developed computer experience and have

  • Good knowledge of FDA Regulations, well-versed in application of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)

  • Must be able to differentiate colors; incumbent cannot be color blind

Education and Experience:

  • BA/BS in business/science or equivalent

  • 3-5 years of experience in Quality with a medical device/Pharma company or other similarly FDA-regulated industry

Physical Demands:

  • Must be able to lift, push, pull and carry up to 25 lbs.

  • The incumbent will stand or sit in stationary positions; walk through the plant, in and between production rooms/areas; use hands/fingers to handle or feel to inspect product,; climb stairs/ladders; stoop, kneel, or crouch in production areas; talk and hear to communicate, discern, convey and exchange information; see to detect, determine, perceive, identify, recognize, judge, observe, inspect, estimate, and assess; smell to detect, distinguish or determine; reaching

Working Environment:

  • Must be able to work in controlled environments requiring special gowning; will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body

  • No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment

  • May work in a cold, wet environment

  • Must be able to work multiple shifts, including weekends

  • Must be able to work longer hours as required

  • May be required to work in a confined area

  • Some Clean Room and cool/hot storage conditions

  • May require immunization before performing work within the manufacturing area

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.