QA Specialist I Doc Control
LSNE - MADISON, LLC
MADISON, WI
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JOB DETAILS
LOCATION
MADISON, WI
POSTED
30+ days ago
thousands of biopharma companies and their patients. We are PCI. Our
investment is in People who make an impact, drive progress and create a
better tomorrow. Our strategy includes building teams across our global
network to pioneer and shape the future of PCI. The Document Control
Specialist will manage and coordinate critical cGMP documentation,
procedures, and records that keep our operations compliant and
audit-ready. In this role, you'll be at the heart of Quality Assurance,
ensuring controlled documents are properly reviewed, approved, issued,
distributed, and archived. You'll also play a key role in driving
process improvements, supporting audits, and collaborating with
cross-functional teams. What You'll Do Maintain quality system
databases, master documents, and numbering logs. Issue, archive, and
manage controlled records (Batch Records, Lab Books, Log Books, Testing
Data Sheets, etc.). Facilitate batch record creation, modifications, and
approvals for client projects. Lead SOP lifecycle management including
biennial reviews, updates, and obsoleting outdated versions. Write and
develop QA SOPs; implement new systems for document control with minimal
supervision. Proof, edit, and process document changes. Assist with
audit preparation, reconciliation, and line clearances (as needed).
Support training and presentations related to document control
processes. What We're Looking For Experience: High School/Associate
degree with 10+ years in a cGMP environment, OR Bachelor's degree with
5-10 years of relevant experience in pharma/biotech manufacturing.
Skills: Strong organizational abilities, MS Office proficiency,
excellent written/verbal communication, and comfort working with SOPs
and spreadsheets. Attributes: Detail-oriented, adaptable, and able to
thrive in a fast-paced, team-oriented environment. Bonus: Prior
pharmaceutical GMP experience and experience supporting audits. #LI-LL1
Join us and be part of building the bridge between life changing
therapies and patients. Let's talk future Equal Employment Opportunity
(EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative
Action Employer. We do not unlawfully discriminate on the basis of race,
color, religion, age, sex, creed, national origin, ancestry, citizenship
status, marital or domestic or civil union status, familial status,
affectional or sexual... For full info follow application link. LSNE is
an EEO/AA Employer and all qualified applicants will receive
consideration for employment without regard to, their race, color,
religion, sex, age, national origin, ancestry, sexual orientation,
gender identity, disability, protected genetic information, protected
veteran status, military service, or other protected status. The
Company's EEO policy, as well as its affirmative action obligations,
include the full and complete support of The Company. *
APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/736A2ED8A6734531
About the Company
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