Location: Juncos, PR Pay Rate: $31.07 / Hourly Work Schedule: This is a 24/7 operation requiring flexibility to work all shifts including weekends.
Summary: In support of company Quality Assurance program, we are seeking a highly motivated and talented staff to join us as Sr. Associate QA, to support and oversee the activities of the Plant Quality Assurance department in our inspection and packaging facility. A strong foundation in application of CGMP in a drug product manufacturing environment is critical, to quickly assess facts and make the appropriate decision when process/product quality may be impacted. The selected individual will perform sampling plans for all drug products, batch record review, audit the inspection and packaging process ensuring compliance to procedures and Quality standards as well as oversee aspects of QA operations within the facility, including but not limited to on-the-floor QA support, deviation investigations, change controls, and SOP revisions.
Responsibilities:
Perform sampling plans for all manufactured products.
Perform batch record review.
Perform SAP transactions.
Perform Trackwise system queries, deviations.
Participate in triage process.
Perform oversight of the process and procedures/GMP tasks.
Compliance review of batch record elements (e.g., MPs, MSRs) and identification of discrepancies.
Participate in internal plant audits.
Work with operations to resolve basic compliance discrepancies.
Assist in Investigations.
May perform work of Associate QA.
Requirements:
Bachelor’s + 6 months of Quality work experience
Experience in plant quality assurance for aseptic areas focused on controls/techniques/behaviors and drug product formulation and filling.
Experience in independent decision making.
Experience in batch record review, audit trail reviews and GDP with focus on data integrity (ALCOA+)
Experience with deviations
Experience with documentation and MES systems such as Veeva, LIMS, PasX
Fluent in Spanish and English
Good communication/escalation skills.
Agile learner with good time management skills.
Punctuality
Applicant Notices & Disclaimers
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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.The pay rate for this position is $31.07/hr.
