Documentation Specialist I- Manufacturing/Quality

Home Documentation Specialist I- Manufacturing/Quality Healthcare & Life Sciences $ 35.46 / Hour location_on Pearl River, New York acute Contract/Temporary favorite_border

JOB ON CANDIDATE PORTAL

COPY LINK link Quality Assurance Specialist - Batch Record Review

Pay Rate:

$35.46/HOUR

Shift:

1st Shift

Location:

Fully Onsite Position Overview Adecco Healthcare & Life Sciences is hiring a Quality Assurance Specialist for our pharmaceutical partner. This position is responsible for reviewing manufacturing batch records, supporting GDPpliance initiatives, and assisting with quality systems activities within a regulated pharmaceutical or biotechnology environment. The ideal candidate will have experience with CAPA, batch record review, technical writing, documentation systems, ERP systems, and quality investigations while maintaining a strong attention to detail in a fast-paced manufacturing setting. Key Responsibilities Track and review manufacturing batch records to ensurepliance with regulatory and GDP requirements Follow up with Manufacturing Technicians to ensure documentation corrections arepleted accurately and in a timely manner Maintain error tracking metrics and support initiatives to reduce recurring GDP violations Coach and support shop floor personnel on Good Documentation Practices (GDP) requirements Identify and escalate documentation and GDP issues that may impact product safety, efficacy, or quality Review batch record structures and rmend process improvements to minimize documentation errors Ensure timely batch record review cyclepletion Participate in deviation investigations and support CAPA creation and follow-up activities Utilize documentation and ERP systems to review records, identify discrepancies, and implement corrective actions Prepare and maintain technical documentation and quality records with a high degree of accuracy Collaborate cross-functionally within manufacturing and quality teams in a regulated environment Required Qualifications High School Diploma with 5+ years of relevant experience OR Associate Degree with 3+ years of relevant experience OR Bachelor's Degree with 1+ year of relevant experience Required Experience & Skills Experience with CAPA, batch record review, and technical writing Strong knowledge of quality systems and documentation practices Experience using documentation systems and ERP systems Ability to identify documentation errors and implement corrective actions Experience within pharmaceutical or biotechnology manufacturing environments Stronganizational skills and attention to detail Ability to work efficiently while maintaining a high degree of accuracy Strong interpersonal,munication, and teamwork skills Preferred Qualifications Manufacturing GDP experience Deviation investigation experience Experience supporting regulated manufacturing operations

Pay Details:

$35.46 per hour Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program,muter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay w applicable. Equal Opportunity Employer/Veterans/Disabled Military connected talent encouraged to To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to adecco/en-us/candidate-privacy The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for Employers San Francisco Fair Chance Ordinance

Massachusetts Candidates Only:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Ref:

US_EN_99_107905_2548368